Safety Scientist Resume Sample
London Haag
1981 Stokes Gardens,
Los Angeles,
CA
+1 (555) 476 2158
Work Experience
Senior Safety Scientist
10/2017
-
PRESENT
Houston, TX
- Ensure all processes’ as described are operational
- Process and evaluate AE reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality and expectedness assessment
- Maintain oversight of all administrative changes and updates
- Ensure compliance with project specific processes and SOPs
- Contribute to the preparation and quality control of responses to authorities, company core data sheets, signal detection and assessment
- Assist with the preparation of Adverse Event Reporting Plans (AERPs)
- Process and evaluate Adverse Event reports according to the customer’s standard operating procedures (SOPs): write the narrative, perform seriousness rating and causality assessment
- Medical review of source documents, coding, data entry, report generation and distribution
- Intake of reportable safety event information from clinical trial investigator sites (Serious Adverse Experiences (SAE), Events of Clinical Interest (ECI), pregnancy and lactation exposure events)
Safety Scientist
08/2012
-
06/2017
Boston, MA
- Prioritize daily work to ensure all events are submitted to case processing for entry into the safety database within the established timeframes.
- Participate as an extended member of the Medical Monitoring Team..
- Intake of reportable safety event information from clinical trial investigator sites (Serious Adverse Experiences (SAE),
- Project oversight and identification of issues
- As subject matter expert, prepares and presents safety data to management and Lundbeck’s Safety Committee
- Requests literature articles
- Prepares and ensures accurate regulatory submissions of IND cross-reporting SUSARs to FDA
Drug Safety Scientist
05/2008
-
06/2012
Houston, TX
- Prepares the US Investigator Safety Letters to the ISL Administration group for onward distribution to the US Investigators
- Ensures monthly reconciliation of AE data exchanged between US vendors and for the US Licensing Agreements
- Manages the US Patient Safety mailbox for AE reports and queries
- Support Clinical Safety Physicians in the safety review process and evaluation of safety data throughout the product lifecycle using a combination of quantitative and qualitative approaches
- Undertake signal detection activities on safety data sets from various sources, such as spontaneous adverse event listings, clinical trial datasets, reports or datasets from observational studies- and present summaries of the data in a meaningful way
- Review publications from the scientific and medical literature for important safety information; summarise and critically appraise the findings from these publications for safety reports (such as periodic safety update reports, signal detection reports, signal evaluations)
- Good knowledge of global and local pharmacovigilance (PV) regulations and legislation, both pre-and post-marketing required
- Proficient with computer programs (Microsoft Outlook, Word, PowerPoint, Excel)
Education
Amberton University
2002 - 2007
Bachelor's Degree in Science
Professional Skills
- Excellent writing skills and synthesis, as well as teaching skills to transmit scientific information to non- scientists
- Excellent oral/written skills in English with a proven ability to write/edit scientific reports
- Proven negotiation and problem-solving skills with all levels of staff including senior management
- Ideally looking for a combination of skills, including aggregate safety reports and safety signal management experience
- Excellent planning and strategic skills to successfully drive laboratory-based activities
- Excellent computer skills, including Microsoft Word, PowerPoint and Excel
- Excellent communication, interpersonal interaction, project management and organizational skills are essential
How to write Safety Scientist Resume
Safety Scientist role is responsible for scientific, interpersonal, research, database, medical, web, databases, training, auditing, security.
To write great resume for safety scientist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Safety Scientist Resume
The section contact information is important in your safety scientist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Safety Scientist Resume
The section work experience is an essential part of your safety scientist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous safety scientist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular safety scientist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Safety Scientist resume experience can include:
- Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: ICSRs, aggregate data, requested line listings Contribute to the preparation and quality control of safety aggregate reports, responses to authorities, company core data sheets, signal detection and assessment
- Experience – 4 years experience in a clinical development setting or 1-3 years Safety experience within the pharmaceutical industry
- Good computing/IT skills
- Excellent attention to detail and accuracy and maintain consistent high-quality standards; including report writing skills
- Coaching and/or management skills
- Literary & laboratory research skills relevant for monitoring web and scientific databases for bibliographic research
Education on a Safety Scientist Resume
Make sure to make education a priority on your safety scientist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your safety scientist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Safety Scientist Resume
When listing skills on your safety scientist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical safety scientist skills:
- Solid communication skills – previous work as a liaison or intermediary is preferable
- Excellent written and verbal communication skills and ability to present and critically discuss clinical data in both internal and external discussions
- Self –motivated, able to prioritize and plan effectively
- Demonstrated project management, and time management/organizational skills
- Team player with ability to function in a multi-disciplinary environment Self motivated, able to prioritize and plan effectively
- Good communication, interpersonal interaction, and organizational skills are essential
List of Typical Experience For a Safety Scientist Resume
1
Experience For Senior Safety Scientist Resume
- Good communication, interpersonal interaction, project management and organizational skills are essential
- Manage multiple client projects simultaneously with good time management skills
- Hands-on experience querying safety databases to report aggregate data
- Experience in leadership and managing projects in a complex cross-functional environment
- Experience in the review and analysis of the literature output
2
Experience For Clinical Safety Scientist Resume
- Establishes and maintains auditable safety files in accordance with Good Pharmacovigilance Practices (GVP) and ICH standards
- Proven ability to conduct data analysis of safety issues/signals
- Working knowledge of ICH Guidelines and US CFR 314.80, 312.32; MedDRA and WHO-Drug coding is desirable
- Requesting additional information from multiple sources, both internal and external to the Company
- Responsible for the timely identification of Safety Reports and/or relevant safety information during the monitoring of the literature
3
Experience For Drug Safety Scientist Resume
- Define microbiological criteria including safety and hygiene/process criteria with relevant sampling plans
- Assist with the preparation of relevant project specific plans and procedures and other plans linked to case processing and literature activities as required
- Responsible for Quality Control of Case Processing and Literature Review deliverables
- Ensure the quality and accuracy of data used to support any regulatory document, including but not limited to: safety reports, aggregate data, line listings
- Ensure the timely and accurate completion of case processing due diligence activities
- Communicate with the Pharmacovigilance medical team to provide medical evaluation and reporting assessment for the cases
4
Experience For R&D Senior Food Safety Scientist Resume
- Comprehensive knowledge of ICH and FDA Regulations and Guidelines both clinical and post marketing
- Knowledge of database management and use of coding dictionaries
- Assess microbiological risk and rank according to specific criteria
- Contribute relevant positions and information to the regulatory and emerging risks platform
- Assist the business in troubleshooting food safety challenges related to microbial hazards
- Identify and participate in relevant ad hoc internal and external scientific working groups
- Provide training on Food Safety related topics
- Alert Project Management when activities fall outside statement of work
- Mentor junior staff or new staff on project and systems
5
Experience For Senior Principal Patient Safety Scientist Resume
- Liaise with both internal and external vendors (clients, patients and health care professionals)
- Direct contact and communication with client
- Ensure all processes as described in relevant procedural documents are operational
- Responsible for processing and evaluating (i.e narrative writing, seriousness rating, causality and expectedness assessment) safety reports originating from clinical studies, literature and the post marketing experience for client products
- Responsible for the timely completion of safety reports for distribution to Health Authorities, clients and client’s partners
- Ensure the timely and accurate completion of reconciliation activities
6
Experience For Safety Scientist Serm Resume
- Prepare and follow through to completion the Safety Database requests (case deactivation, Output Request, Change Control and User Access Request Forms as appropriate) for UBC PV management review and approval
- Assist, in conjunction with the Argus team and UBC PV management, in User Acceptance Testing (UAT), including, but not limited to, coordination, generation, and execution of test scripts
- Participates in project specific internal teleconferences/meetings and client specific teleconferences/meetings for operations
- Alert UBC PV Management when activities fall outside contracted tasks in Scope of Work (SOW) or applicable procedural documents
- Provide and assist with appropriate documentation of non-compliance with regulatory requirements and / or applicable procedures in Safety Incident Reports (SIRs), Problem Notification Forms and Corrective and Preventive Actions (CAPA) as required
- Support in client audits and regulatory inspections from a pharmacovigilance operations standpoint
- Intake of reportable safety event information from clinical trial investigator sites (Serious Adverse Experiences (SAE), Events of Clinical Interest (ECI), pregnancy and lactation exposure events) 2. Review, manage and create case reports for all reportable events
- Participate as an extended member of the Medical Monitoring Team
7
Experience For Medical Safety Scientist Resume
- Events of Clinical Interest (ECI), pregnancy and lactation exposure events) 2. Review, manage and create case reports for all reportable events
- Maintain daily communication and collaboration with all functional groups involved in the management of Pharmacovigilance process including Client, safety CROs and external data management vendors
- Coordinate the SAE reconciliation on a continuing basis
- Communicate directly with investigators and other site staff on safety information/issues as necessary
- Prepare periodic Pharmacovigilance Reports for Regulatory authorities,
- Supports the Product Safety Team (PST); contributes to the benefit risk evaluation and to safety risk management
- Contributes to preparation and review of periodic safety reports and other safety related documents (Drug Safety Reports, Ad hoc analyses requested by Regulatory Authorities) in accordance with regulatory requirements and standard operating procedures
- Knowledge of ICH, EMA and FDA Regulations and Guidelines both clinical and post marketing pharmacovigilance and clinical safety
8
Experience For Global Patient Safety Scientist / Manager Resume
- Train and mentor personnel assigned to project teams
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues
- Support the preparation and maintenance of Risk Management plans
- Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
- Lead/support PDS post-marketing safety study activities
- Coordinate safety activities between PDS and internal and external partners
- Provide constructive feedback for performance improvement when appropriate
- Coordinates entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources
9
Experience For Food Safety Scientist Resume
- Ensures provision of safety information/acknowledgement to marketing partners/other third party partners/Global Medical Safety within the internal and contractual timelines
- Coordinates and is responsible for assessment of incoming information from multiple sources, both internal and external to the Company
- Contribute to quality improvement: Review, prepare, and/or update local and global SOPs and working instructions as required
- Assist with assessment of incoming information from multiple sources, both internal and external to the Company
- Coordinates and is responsible for the quality review of data captured in the Global Safety Database
- Entry of relevant/required safety data into the Global Safety Database from spontaneous sources, clinical trials and other solicited sources
- Provision of safety information/acknowledgement to marketing partners/other third party partners/Global Medical Safety within the internal and contractual timelines
- Assist in the quality review of data captured in the Global Safety Database
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and tracking and evaluating potential issues
10
Experience For Associate Director, Patient Safety Scientist Resume
- Prepare and review periodic aggregate safety reports (PBRER / PSUR, DSUR, EU renewal and other Annual Safety Reports) in accordance with regulatory requirements and standard operating procedures
- Develop appropriate training for functions in the area of microbiology and food safety. Act as mentor to new employees in FS and MDLZ & MEU Quality functions.
- 2+ SAE case reporting ( IN/SUSAR, PSUR, DSUR) & maintenance
- Reviews and comments on documents and line listings from GPV&E, other BMS departments, and other drug development/ marketing partners and contractors
- Follows BMS GPV&E and R&D SOPs, drug safety coding conventions, and work-aids
- Proficient with computer programs (MS Word, PowerPoint, Excel)
- Manage reporting/submission/distribution of safety reports/updates/information (e.g.SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR) to Local Health Authorities and/or clinical operations in cooperation with other Country Organization Departments, if applicable
List of Typical Skills For a Safety Scientist Resume
1
Skills For Senior Safety Scientist Resume
- Proven ability to meet strict deadlines; manage competing priorities and ability to be flexible and receptive to changing demands
- Data analytics and coding skills
- Prefers a healthcare background in pharmacy, nursing or related area or experience in clinical trials or post clinical trial experience
- Technical Skills: Microsoft Word, Microsoft Excel, basic Accounting
- Patient safety experience and/or at least 3 years clinical or pharmaceutical experience
- Prior experience in laboratory management (i.e. students, postdocs, scientists, laboratory support staff)
- Be able to work effectively with multiple assignments
- Demonstrates the ability to multi-task, and flexibility to meet changing business priorities
2
Skills For Clinical Safety Scientist Resume
- Competent medical/scientific writing skills
- Qualified candidates need to have 3 or no less than 2 years of prior PV experience
- Need to have prior safety data experience in Argus, ARISg or similar datebases
- Prior industry experience in drug safety, clinical development or medical affairs is desirable
- Prior industry experience in drug safety, clinical development or medical affairs (at least 2 years)
- Operate independently by planning, scheduling and arranging activities in accomplishing objectives
- Experience working in a pharma/clinical setting
3
Skills For Drug Safety Scientist Resume
- Experience in leading the preparation and authoring of aggregate safety reports as well as benefit risk statements
- Administrative experience such as data entry and mapping
- Proven ability to follow instructions/guidelines, work independently and takes ongoing initiative
- Previous experience with authoring Periodic Reports
- Experience in working with NCE and NBE
- Good understanding in gum and/or confectionary (low moisture) technology
- Strong knowledge of international drug regulation including GCP, GVP and GMP
4
Skills For R&D Senior Food Safety Scientist Resume
- Flexible, able to cope with changing priorities, ability to handle uncertainty
- Excellent attention to detail and accuracy and maintain consistently
- Experience within safety/PV
- Strong knowledge in the field of in vitro toxicology with emphasis on in vitro systems and/or biomarkers
5
Skills For Senior Principal Patient Safety Scientist Resume
- Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation
- Knowledge and experience of the principles of causality assessment and the evaluation of safety signals
- Strong and broad background in applied food microbiology to include fermentation, food pathogens, environmental contaminants, and/or food spoilage organisms
- Excellent knowledge of Lifecycle Safety services and processes
- Professional experience in quality and food safety
- Experience in pharmaceutical drug development
- Strong knowledge of GCP and ICH regulations
- Demonstrated ability to influence and collaborate internally across MRL at all levels and externally with business partners and vendors
- Experience in drug safety
6
Skills For Safety Scientist Serm Resume
- Experience with case narrative writing for Adverse Event Reports
- Experience in PV regulatory reporting activities
- Good knowledge of global and local PV regulations and legislation, both pre-and post-marketing required
- Researching new raw data AE terms, mapping of raw data AE terms to dictionary codes and coding conventions
- Processing, follow-up and expedited reporting of spontaneous case reports of adverse events and pregnancies
7
Skills For Medical Safety Scientist Resume
- Answering telephone inquiries from healthcare professionals relating to adverse event case reports
- Working knowledge of epidemiology
- Position requires a tolerance for working in outdoor environments, including prolonged walking and standing on various terrain in a range of weather conditions
- Able to complete complicated tasks independently, capable of providing coaching and sharing best practice with junior Safety staffs
- Proficient with case processing including use of coding dictionaries, case narratives preferably within ARISg and/or Argus
8
Skills For Global Patient Safety Scientist / Manager Resume
- Administrative activities relating to case processing, for self and on behalf of Clinical Safety Group
- Knowledge and firm understanding of FDA expedited reporting requirements for Clinical Trial SUSAR reports
- Monitor safety reports receipt, triage evaluation, tracking, entering, distribution, query generation, and the quality control of all safety data
- Ensure the punctuality and timeliness in the collection, processing and regulatory reporting of SAEs
- Ensure the accurate, prompt, and consistent coding of adverse event data and drugs into the Global Safety Database, coding of terms (MedDRA, WHO Drug, etc.)
- Coordinates receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
9
Skills For Food Safety Scientist Resume
- Receipt and processing of incoming safety information from multiple sources, both internal and external to the Company
- Ensure training, mentoring and oversight of staff as applicable
- Liaison with medical personnel in regarding adverse event reports
- Support the preparation and maintenance of safety sections of the Company Core Data Sheet Lead/support PDS post-marketing safety study activities
- Liaison with medical personnel in the company regarding adverse event reports
- Work with Regulatory and Publishing for completion of the PAIR submission to FDA
- Knowledge and firm understanding of the FDA Final Rule Requirements
- Basic understanding of drug development process
- Basic understanding of drug approval process in major countries
10
Skills For Associate Director, Patient Safety Scientist Resume
- Working in Health Industry
- Expert knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance
- Work independently and as a team player, working in a global cross functional environment
- Process and evaluate AE reports according to the customer’s standard
- Broad understanding of scientific and medical concepts
- Build team capabilities through proactive coaching
- Contributes in the conduct of ongoing literature safety surveillance for
List of Typical Responsibilities For a Safety Scientist Resume
1
Responsibilities For Senior Safety Scientist Resume
- Excellent communication and collaboration skills to influence and to work with multidisciplinary teams and manage external network
- Strong communication skills, open to communicate and build network internally and externally
- Literary research & laboratory research skills to use web search and scientific databases for bibliographic research and scientific monitoring
- Strong competencies and experience in food safety and microbiology required
- Strong competencies and experience in toxicology, FS risk assessment, to ensure authority and credibility of the scientific opinions issued
- Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company and academic setting)
- Experience working in teams, including supporting other team members when necessary and the ability to lead a team
- Experience in a manufacturing site managing quality and food safety management systems responsible
2
Responsibilities For Clinical Safety Scientist Resume
- Food manufacturing experience involving QA, sanitation, or food safety
- Experience in authoring of aggregate safety reports
- Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance
- Skill in statistical management of data and the implementation of probabilistic approaches
- Build strong collaborative relationships across engineering, IE, PPI, PI, operations and commercial
- Review micro verification data on a daily weekly basis including on weekends and operate the site escalation process as necessary
- Experience in Quality and Food Safety in a manufacturing environment
- Professional experience in quality and food safety
- Performing required safety activities in the absence of the Local Patient Safety Officer (LPSO) or deputy LPSO
3
Responsibilities For Drug Safety Scientist Resume
- Responsible for overseeing specific aspects of adverse event processing and reporting for assigned investigational and marketed products
- Codes safety data using MedDRA dictionary, WHO-Drug and other coding schemes
- Serve as a resource for GPV&E information and help develop and participate in and/or lead teams involved with developing or revising GPV&E SOPs
- Support Drug safety physicians in handling issues related to both clinical and post-marketing safety, as needed
- Responsible for overseeing pharmacovigilance activities related to clinical trials and postmarketing safety studies
- Lead preparation of RMP and post-marketing safety monitoring activities
4
Responsibilities For R&D Senior Food Safety Scientist Resume
- Works with GPV&E vendors & partners providing oversight/guidance for the ESR/SUSAR process
- Completely and accurately documents reports involving adverse event information
- Carry out signal detection activities utilizing internal and external sources of investigational or marketed product safety data
- Ensure that all safety deliverables are produced and executed according to SOPs and guidelines
- Contribute and provide support required to respond to medical inquiries regarding safety issues, ad hoc requests from regulatory agencies, etc., as needed
- Ensure scientific relevance of deliveries and their right understanding by internal customers
- Provide technical support to GPV&E medical review safety physicians (MRSP) including review and interpretation of source documents
- Review and comment on documents and line listings from GPV&E, other BMS departments, and other drug development/marketing partners and contractors
- Relevant pharmaceutical or medical device safety
5
Responsibilities For Senior Principal Patient Safety Scientist Resume
- Utilizes BMS safety and clinical databases to prepare contextual summaries for expedited safety reports
- Performs analysis of Similar Events for potential DILI and events of special interest cases
- Serves as a resource for GPV&E to provide SUSAR-related information; helps develop and participate in and/or lead teams involved with developing or revising GPV&E SOPs
- Ad Hoc member of Medical Surveillance Team
- Receives safety related information via telephone calls, faxes, e-mails, web portals, etc., from health care professional, study coordinators, patients, caregivers and other parties reporting potential adverse events (AE)
- Provides Notification to sponsor, clinical CRO, internal team and others within 24 hours of receipt
- Enters data into safety database
- Implements the generation of queries on all serious adverse events (SAE) reports for the clarification of adverse event data as needed and within required timelines
6
Responsibilities For Safety Scientist Serm Resume
- Assess listedness and confirms seriousness of the report
- Prepares draft MedWatch and CIOMS I form
- Submits cases to Health Authority, Investigators, IRBs as needed
- Performs file creation, retention and maintenance (paper and electronic)
- Present scientific analyses and data for safety teams and cross-functional governance bodies, and/or provide support for the appropriate safety deliverables for such meetings (e.g. Risk Management Committee meetings)
7
Responsibilities For Medical Safety Scientist Resume
- Coordinate and contribute to the production of all relevant regulatory documentation, e.g. ASR, DSUR, PSUR
- Contribute drug safety input to activities to define and implement the Clinical Development strategy for a product or group of products
- Support and collaborate with business partners around safety data evaluations and safety data exchanges, including the creation of safety data exchange agreements, review of safety materials received from our partners
- Manage and maintain pharmacovigilance agreements as needed
- Demonstrated ability to write reports based on the aggregate data and safety analysis conducted from literature, product quality complaints, and clinical/nonclinical safety data
- Extensive medical knowledge of methods to assess causality relationship between adverse events and administration of Company products
- Receives safety related information via telephone calls, faxes, e-mails, web-portals, etc., from Sponsors, CROs, healthcare professionals, study coordinators, allied health personnel, patients, caregivers and other parties reporting potential adverse events
8
Responsibilities For Global Patient Safety Scientist / Manager Resume
- Prepares draft MedWatch and CIOMS I forms
- Follows up on all SAE reports within required timelines
- Receives safety related information via telephone calls, faxes, e-mails, web-portals, etc., from Sponsors, CROs, healthcare professionals, study coordinators, allied health personnel, patients, caregivers and other parties reporting potential adverse events Enters data into safety database
- Knowledge of Good Pharmacovigilance Practices (GVP)
- Medical Background: Nursing, Pharmacy/PharmD, or health care related field or equivalent is required
- Familiarity with safety databases, data entry platforms, adverse event data collection process, case processing, call center activities, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements is required Good interpersonal and communication skills
- Carry out pharmacovigilance and risk management activities for specific product or products
- Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues; report on outcomes
9
Responsibilities For Food Safety Scientist Resume
- Support the preparation and maintenance of Risk Management plans,
- Prepare and review periodic safety reports (PBRER / PSUR, DSUR, EU and noational renewalsand other Annual Safety Reports, aCOs) in accordance with regulatory requirements and standard operating procedures, as well as the preparation and maintenance of safety sections of the Company Core Data Sheet
- Plan/Conduct/Support signal detection and evaluation according to SOPs and guidelines, and medical review of individual case safety reports (ICSRs)
- Contribute to regulatory agency submissions (IND applications, NDAs, MAA’s, Variations, Renewals, aCOs) by reviewing safety data and preparing relevant sections of the filing documents and submission packages
- Provide safety content review of clinical protocols, study reports, Investigators Brochure and other related documents to ensure alignment with CDP ; support PASS study (design and assessment)
- Supports the clinical teams in bringing the safety expertise for interaction with Health Authorities, Data Safety Monitoring Boards , independent monitoring committee meetings, Investigators and internal stakeholders
10
Responsibilities For Associate Director, Patient Safety Scientist Resume
- Contributes to scientific publications from a safety perspective
- Identify and characterize microbiological hazards related to Danone products
- Deliver quantitative and qualitative microbiological risk assessments (QMRA)
- Provide technical input for mitigation/control of microbiological risks through advice, guidelines, tools
- Coordinate/organize microbial challenge studies and method evaluations as needed
- Contribute to the implementation of recognized procedures and processes in the field of risk assessment
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