Drug Safety Associate Resume Sample
Norbert Willms
98473 Katelyn Corner,
Boston,
MA
+1 (555) 338 2874
Work Experience
Drug Safety Associate
11/2017
-
PRESENT
Dallas, TX
- Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are required
- Highly organized, analytical, and logical in approach to all assigned tasks
- Two- three years’ experience in drug safety in the pharmaceutical industry or other comparable experience
- Manage workflow of all SAEs received into the department to facilitate routing, review/approval, and timely case finalization and archiving
- Intake and documentation of receipt of SAE reports, follow-up information and source documents
- Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated
- Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
- Other activities relating to case processing as appropriate per case, including but not limited to
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards
Senior Drug Safety Associate
10/2011
-
09/2017
Boston, MA
- Proven ability to influence and collaborate with business stakeholders effectively and in a positive manner
- Great project management skills and ability to execute and manage multiple projects and deadlines with shifting priorities and resources in a fast-paced working environment
- Maintaining an excellent knowledge of case processing conventions and guidelines, client’s procedures and international drug safety regulations
- External – TGA, MedSafe, Consumers, health care professionals, Medicines Australia, and others
- Internal – personnel from various departments/functions (i.e. Regulatory Affairs, Clinical Operations, Sales, Marketing, Medical Affairs, Health Care Compliance, Finance, etc.)
- Write and send SAE queries to Investigative sites, CRAs, and CTM’s utilizing Query templates and Query Activity tracking within ARGUS
- BS/BA: 1-2 years of relevant experience
- Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry or in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance
Drug Safety Associate / Specialist
12/2007
-
07/2011
New York, NY
- Knowledge of medical and dmg terminology desirable
- Familiarity of Good Clinical Practice (GCP) related to clinical safety documentation
- Familiarity with ICH Guidelines
- Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigation products
- Familiarity of worldwide regulatory requirements and reporting of adverse event for both marketed and investigational products
- Submission of safety reports to investigators via SIS (Safety Information System)
- Assist with measuring investigative site performance in conducting required tasks in SIS
- Assist with unblinding of SUSARs, as required
- Support collection and review of metrics for measuring reporting compliance Support Global Pharmacovigilance Information Office (GPIO) in the collection and organization of global PV requirements
Education
Colorado Technical University - Pueblo Campus
2002 - 2006
Bachelor's Degree in Health Sciences
Professional Skills
- Excellent organizational skills, demonstrated ability to prioritize multiple projects
- Proven experience and report writing skills in accordance with agency requirements for content, format and timelines
- Excellent communication and interpersonal skills with the ability to effectively influence others
- Strong computer skills with experience in Word, Excel and Outlook
- Analytical and organizational ability, able to prioritize with problem solving skills under minimal supervision
- Effective communicator with excellent verbal and written skills
- Strong organizational skills, detail oriented, ability to adapt to change
How to write Drug Safety Associate Resume
Drug Safety Associate role is responsible for organizational, medical, research, reporting, excel, manufacturing, training, database, oncology, insurance.
To write great resume for drug safety associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Drug Safety Associate Resume
The section contact information is important in your drug safety associate 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 Drug Safety Associate Resume
The section work experience is an essential part of your drug safety associate 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 drug safety associate responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular drug safety associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Drug Safety Associate resume experience can include:
- Provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs)
- Ensure accurate transfer of information from initial and follow-up source documents or E2B inputs for adverse event reports to appropriate fields within Argus; code adverse events using MedDRA, create narrative of the adverse events, and manage case reports within the Argus workflow to meet local and global regulatory timelines
- Process case-related information including interpretation of medical conditions, lab results, and procedures; ensuring proper coding of data into the global safety database
- Prior work experience with Pharmacovigilance database is an asset
- Understanding and application of good documentation
- Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations
Education on a Drug Safety Associate Resume
Make sure to make education a priority on your drug safety associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your drug safety associate 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 Drug Safety Associate Resume
When listing skills on your drug safety associate 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 drug safety associate skills:
- Demonstrated problem solving skills including successful resolution and proactivity
- Attention to detail along with strong scientific, analytical and conceptual skills and the ability to reach reasoned conclusions
- Excellent written, oral communication, personal organizational skills and resourcefulness
- Excellent verbal/communications skills
- Prior experience with adverse event reporting
- Effectively troubleshoot and recommend solutions as issues arise
List of Typical Experience For a Drug Safety Associate Resume
1
Experience For Senior Drug Safety Associate Resume
- Demonstrate strong organizational skills, including the ability to prioritize work
- Collect, document and evaluate adverse event information from Healthcare professionals using medical knowledge, experience, and communication skills
- Prior experience with Drug Safety database entry and narrative writing
- Experience working with data extracted from a database
- Maintains 100% compliance with regulatory reporting. Maintains Good Clinical Practices and complies with FDA regulations
- Demonstrate knowledge of applicable clinical trial regulations
2
Experience For Drug Safety Associate, Case Processing Resume
- Supporting the training of new personnel on reporting of adverse events
- Preparing metric reports pertaining to Drug Safety department for management
- Participating in the creation and compliance of FP policies and department standard operating procedures
- Contributing to inspection readiness planning, as needed
- Using medical / pharmacological expertise to assist with data review, literature review and signal detection processes
- Working knowledge of pharmaceutical development process
- Primary client contact in partnering with the sponsor, their sites, etc. as necessary, regarding safety issues in support of the case processing team
3
Experience For Drug Safety Associate / Specialist Resume
- Assist in project specific safety database setup, development of data entry guidelines, user acceptance testing, policies and training materials
- Assists in the review and implementation of training and cases processing procedural documents
- Support the preparation and conduct of internal audits or PV inspections as required and contribute to inspection readiness on an ongoing basis
- Proactive and timely communication and escalation of issues or deviations identified relating to any aspect of PV processes
- Assists in obtaining additional report information from clinical sites, CPMs/CRAs and service providers
- Compile the safety data into the relevant sections of periodic reports such as PBRER, PADER, and DSUR according to the client
- Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work
- Review and evaluate AE case information to determine required action based on and following internal policies and procedures
4
Experience For Medical Information / Drug Safety Associate Resume
- Process all incoming cases in order to meet timelines
- Apply clinical judgment when interacting with healthcare professionals and consumers to obtain and follow up on reports of possible adverse events
- Liaise with other Safety and Compliance Associates to ensure timely processing
- Healthcare professional background including but not limited to, pharmacist, nurse, medical doctor, and dentist
- General working knowledge of document management systems
- Supports Drug Safety Management in ensuring PV compliance with global company and local regulatory authority PV requirements
5
Experience For UBC Senior Drug Safety Associate Resume
- Perform safety review of clinical and diagnostic data as part of case processing
- Generation of project specific procedures/safety management plan/Sae forms templates using the departmental guidance templates
- Act as Pharmacovigilance lead for global and local US projects assigned supporting your line manager and Director
- Liaise with other ICON departments and/or other Sponsor vendors such as data management and clinical project management, medical writing, etc
- Extensive knowledge of regulatory reporting obligations in both US and ROW
- Generate medical narratives derived from the collection of adverse event information and verify medical coding in the safety database system
- Ensure case receives appropriate medical review and prepare follow-up correspondence consulting medical staff accordingly
- Assist in the review of cumulative safety data for submission to Drug Safety Monitoring Boards (DSMBs), regulatory authorities or clients
6
Experience For Drug Safety Associate, Taiwan Resume
- Assist with SAE reconciliation activities with internal departments and external partners as needed
- Ensure timely preparation & submission of reports to regulatory agencies in accordance with applicable regulations - including United States DSUR and global PBRER reports
- Generate aggregate safety data output from the Safety database for activities related to compliance, metrics, monitoring, KPIs or internal stakeholder or Partner related activity
- Participate in audit preparedness and support Partner and/or Regulatory audit
- Vendor and CRO oversight
- Conduct regular reconciliation with health authorities, medical information (spontaneous),
7
Experience For Drug Safety Associate, QC Focus Resume
- Assess the nature of the business activities and determine the applicable PV requirements
- Liaise with other departments to ensure processes and systems are established and maintained to enable oversight and compliance of all affiliate business activities with PV implications
- Development of PV clauses for third party agreements
- Maintain local DS procedures with ongoing review for efficiency and review against updates to global Roche requirements and applicable local regulations and laws
- To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports
8
Experience For Drug Safety Associate Resume
- To maintain the local archive of safety reports
- To maintain current awareness of local and global safety regulations
- To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg and E2B
- To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling
- Receipt and allocation of case reports and other safety relevant information in accordance with relevant procedures and within applicable business timelines
- Follow-up activities on case reports as required and in accordance with relevant procedures and within applicable business timelines
- IRT/OST workflow checks to ensure compliance with regulatory and internal business timelines for submission of case reports to TGA
9
Experience For Senior Drug Safety Associate Resume
- Support the Group Drug Safety Manager in the review and update of case submission rules for Australia
- Training of third party vendors conducting PV activities on behalf of Roche Australia and of Roche employees/contractors regarding assessment and processing of case reports and other PV activities as required
- Other activities relating to case processing as appropriate per case, including but not limited to single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy
- Proficient skill level in Adobe Acrobat, Microsoft Word and Microsoft Excel
- Demonstrates a practical and innovative approach to continual improvement, implementation of change and inspection readiness within Drug Safety
- Completion of all assigned training on company and GMSO procedural documents relating to case processing
- Oriented to quality, attention to detail and accuracy
10
Experience For Drug Safety Associate, Case Processing Resume
- Interacts with partners and service providers in the receipt of safety information, notification to other parties, reconciliation and compliance review
- Assesses adverse event reports for accuracy and completeness
- Performs quality control review of individual case safety information and aggregate data outputs
- Generates safety reports and monthly/summary report outputs from the safety database
- Works closely with other Drug Safety personnel and the clinical teams to communicate safety information internally
List of Typical Skills For a Drug Safety Associate Resume
1
Skills For Senior Drug Safety Associate Resume
- Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations is required
- Experience in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
- Demonstrated understanding of the assessment and processing of safety reports
- Proven ability to analyze and interpret aggregate patient safety data relating to drug products
- Maintaining an excellent knowledge of data capture conventions and guidelines, client’s procedures and international drug safety regulations
- Proven ability to work well with others in a proactive, positive, and constructive manner. A positive attitude for driving ambiguous situations
- Work in a dynamic environment and manage competing priorities
- Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS, Variations) for biologic and/or drug products
- Regulatory, Manufacturing, QA/QC experience
2
Skills For Drug Safety Associate, Case Processing Resume
- Experience in using drug safety database (ARISg or Argus)
- Experience in using MedDRA and WHO-Drug dictionaries
- Experience with exchanging safety data with business partners or affiliates
- Proven proficiency using MS Word, Excel, Power Point and Outlook
- Experience working in a pharmacovigilance department at a pharmaceutical company
3
Skills For Drug Safety Associate / Specialist Resume
- Shares of ideas and suggestions with team members ensuring effective communication
- Experience using or familiarity with ARGUS or other safety database applications
- Experience using or familiarity with MedDRA
- Demonstrated excellence in the processing of clinical safety data for investigational products in the biopharmaceutical industry
- Relevant drug safety experience
- Related experience gained in healthcare environment is an advantage
- Prepare or QC consolidated clinical trial case narratives
- Receive and process all reports of adverse drug experiences in accordance with established Local
- Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
4
Skills For Medical Information / Drug Safety Associate Resume
- Good understanding of safety regulations
- Ensuring timely reporting of SAEs/AEs to Regulatory Authorities, and cross-reporting to pharmaceutical partners
- Tracking and filing of submission cases as required
- Working knowledge of US regulations and guidances pertaining to post-marketed Human Drug products
- Conducting periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision
5
Skills For UBC Senior Drug Safety Associate Resume
- Understanding of medical terminology and ability to summarize medical information
- Coding all AEs in MedDRA independently
- Participating in the preparation of aggregate safety reports, such as biannual safety reports to Ethics Committees and annual reports to regulatory authorities
- High level of computer literacy, particularly in the use and management of Drug Safety databases including ICSR data entry and regulatory reporting
- In-depth understanding of the ICSR assessment and reporting process
- Collect and review metrics for measuring reporting compliance
- Perform coding review for adverse events, medical history, and concomitant medications from ongoing clinical trials
- Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness
6
Skills For Drug Safety Associate, Taiwan Resume
- Completion of training relating to relevant PV Agreements for assigned products
- Assists in the development of safety surveillance processes and writing corresponding SOPs
- Determine expectedness/listedness against appropriate label and identify clinically significant information missing from initial reports ensuring collection
- In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing
- Proven ability to interpret and follow the patient safety guidelines of the FDA and comparable international regulatory organizations such as the International Conference on Harmonization
- Working knowledge of FDA and international pharmacovigilance and clinical safety regulations and guidelines
- Extensive working knowledge of FDA regulations, FDA guidance and ICH guidance; some familiarity exposure to EMEA regulations
7
Skills For Drug Safety Associate, QC Focus Resume
- Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports etc
- Maintain local drug safety reporting requirements
- Knowledge of worldwide regulatory requirements and the reporting of adverse events for both marketed and investigational products
- Measure investigative site performance in conducting required tasks in ISIS
- Un-blinding of SUSARs, as required
8
Skills For Drug Safety Associate Resume
- BS, MS or PhD in Biology, Chemistry, Engineering or related field
- Work well in cross-functional teams in a fast-paced challenging environment
- Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
- Attend internal, drug safety and project specific training sessions
- Participate in interdepartmental activities and assist management with weekly and monthly project status reports including quality review findings and metrics
- Correspond and interface with CRO’s regarding collection of safety information for development products
- Participate in clinical team meetings supporting the Ironwood development portfolio as representative of Drug Safety, when needed
- Vendor training and oversight
- Quality review of case reports processed by third party vendors or in-house ensuring compliance with applicable procedures
9
Skills For Senior Drug Safety Associate Resume
- Participate in designated activities to support revision/creation of case processing procedural documents
- Participation in inspections and audits as identified, including interviews and provision of requested data
- Assists with the processing of adverse event reports from clinical sites, partner companies and marketed product use
- MedDRA and WHO-DD coding
- Collect data regarding adverse events
10
Skills For Drug Safety Associate, Case Processing Resume
- Maintains up- to-date information on local Regulatory Authority out of hour’s contacts
- Reviewing ancillary documentation accompanying ICSRs and identifying the relevant information for processing and electronic capture on the client’s safety database
- Prepares the respective submission documents to Health Authorities
- Supervision of proper flow of confirmations of receipt of documentation sent to the Health
- Preparation and everyday distribution of respective DS&E documents externally
- Participation in the verification process of data correctness in the global safety database
- Verification of correctness and compliance of documentation sent to CPO DS&E Department
- Quality control of case reports, line listings, and tabulations
List of Typical Responsibilities For a Drug Safety Associate Resume
1
Responsibilities For Senior Drug Safety Associate Resume
- Experience preparing and finalizing documents in Word and Adobe
- Training of third party vendors conducting PV activities on behalf of Roche Australia
- Ensure all ICON, Sponsor, and regulatory timeframes are met for the processing andreporting of safety information
- Participate on cross functional, multidisciplinary teams and contribute to defining aggregate reporting guidelines
- Partner with Case Processing, Quality/Compliance and Safety Systems staff to ensure efficient and compliance aggregate reporting processes
- In-depth understanding of the aggregate reporting process
2
Responsibilities For Drug Safety Associate, Case Processing Resume
- Holds the training for GRA project team, Investigators and other departments on regulatory reporting activities. Generation of project specific procedures
- Act as safety reporting lead for multiple projects providing management/project management support
- Perform domestic and foreign case assessment for Health Canada reporting
- Request product complaint investigation (e.g. PQMS number) on appropriate cases according to the SOP
- Provide mentoring and oversight of Drug Safety Associate staff
- Support the preparation and conduct of internal audits or inspections as required and contribute to inspection readiness on an ongoing basis
3
Responsibilities For Drug Safety Associate / Specialist Resume
- Receives direction and guidance from more senior colleagues and managers
- Interacts with different members of the clinical departments and regulatory affairs
- Interact with a variety of Array departments, service providers and Array partners
- Lead/Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements
- Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e. PSURs, PADER, DSURs, PBRER’s, Addendum to Clinical Overview’s, Addendum to PSUR’s, Summary Bridging Report’s and RMP Updates)
- Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template
- Create all documents in accordance to all applicable SOPs, and convention of the client
- Plan, organize, and manage daily work to meet service level timelines and deliverables
- Provide word and PDF versions of the final signed documents to the client
4
Responsibilities For Medical Information / Drug Safety Associate Resume
- Participate in internal and external audits and inspections by clients and health authorities
- Responsible for data entry of individual case safety reports into the safety database
- Follow-up on reconciliation of discrepancies
- Perform submission activities when trained and assigned
- Responsible for case intake, duplicate check, and registration
- Maintain log of source documents and other communications
- Perform literature review activities when trained and assigned
5
Responsibilities For UBC Senior Drug Safety Associate Resume
- Timely process or QC clinical trial cases in ARISg safety database
- Prepare, track, and follow up case queries
- Perform routine SAE reconciliations
- Familiarity with key safety regulations such as FDA, ICH, EMA
- Review and determine regulatory reporting requirements based on assessment of seriousness, causality and expectedness/listedness in accordance with regulatory guidelines and product labeling
- Prepare adverse events reports for submission to Health Canada within the appropriate reporting timeframes. Verify accuracy, completeness and validity of report information
- Evaluate adverse event reports, assesses regulatory status (seriousness and expectedness/relatedness)
- Process adverse event reports from spontaneous sources, clinical trials, studies and marketing activities (including healthcare professionals and consumers) in accordance with company standard operating procedures (SOP) and guidelines for maintaining regulatory compliance. The sources include mail, voicemail, phone, fax and other electronic means
- Determine and conduct follow-up actions as required with appropriate communication methods (e.g. fax, email, telephone)
6
Responsibilities For Drug Safety Associate, Taiwan Resume
- Provide coverage to all products/devices as assigned
- Respond to GMS (Global Medical Safety) and international affiliates as required for operational (e.g. queries), compliance and/or safety functions
- Provide safety reporting training to third-party vendors (market research, patient assistance providers) with manager’s oversight. Train DSS team members as assigned
- Relevant clinical practice or pharmaceutical industry
- Mentor and guide the activities of the Drug Safety Associate
- Perform case processing for serious adverse events, serious and non-serious adversedrug reactions, and other medically-related project information such as adverse events ofspecial interest and clinical endpoints
- Assist in ensuring the completion of all departmental project activities accurately inaccordance with ICON standards, regulatory requirements, and contractual obligations toSponsors
- Min 1-2 yrs relevant exp in pharmacovigilance
- Proactively maintains a current awareness of the internal and external environments and seeks opportunities to apply this knowledge and upskill the Drug Safety department
7
Responsibilities For Drug Safety Associate, QC Focus Resume
- Performing active follow-up via telephone contact with consumers and health care professionals
- Monitors status of ICSR follow-up letters to ascertain they are being sent out in the required timeframe
- Leads specific projects as nominated by the Group Drug Safety Manager
- Attend study meetings with the clinical team and participate in client meetings related to safety oversight and management, as well as lead PV project team meetings internally and with the client
- Assist with identifying out of scope activities in conjunction with the PV Project lead (as applicable)
- Preparing clinical narrative summaries independently for AE reports from clinical studies and spontaneous post-marketing reports and formulates follow-up information requests
- Working with Clinical Research Department and Contract Research Organizations, sometimes in a lead capacity, regarding information exchange and safety exchange agreements
8
Responsibilities For Drug Safety Associate Resume
- Triages assigned adverse event reports using medical and regulatory expertise. Enters and maintains the events in the electronic drug safety database
- Responsible for obtaining follow-up information from healthcare professionals and consumers
- Scan, import and QC all adverse event source documentation into the Individual Case Safety Report (ICSR)
- Mentors and provides safety support to Drug Safety Associates
- Monitors DSA case workload on a weekly basis and escalates issues/concerns to Data Manager
9
Responsibilities For Senior Drug Safety Associate Resume
- Performs weekly reconciliation of adverse event and product complaint reports with Quality Assurance and Medical Information departments respectively. Maintains verification of reconciliation and email correspondence in Drug Safety shared drive
- Work closely with Pharmacovigilance Data Manager and Quality Manager and provide back-up in their absence
- Develops follow-up processes (letters, questionnaires and phone contact) to obtain relevant medical information pertinent to case analysis and signal detection
- Co-author / co-develop data entry process instructions and update accordingly when processes and procedures change
- High level of computer literacy, particularly with safety database functionality
- Report endpoints to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines
- Prepare timely pharmacovigilance reports for products and safety issues, including Individual Case Summary Reports (ICSRs) of Serious Adverse Events (SAEs), Annual IND reports, European Annual Safety Reports (ASRs), Development Safety Update Report (DSUR) Periodic Reports (PRs) line listings, and aggregate reports
- Representing Drug Safety Department in study team meetings
- Facilitating the request for listings of similar events from the drug safety vendor, for the analysis of similar events as needed
10
Responsibilities For Drug Safety Associate, Case Processing Resume
- Supporting the identification of new data management tools and innovative approaches
- Ensures filing of SAE reports, SUSARS, and safety documents
- Communicates and updates Team of any process related issues/ concerns Assists with special projects and other ongoing safety activities and programs as needed
- Manage scheduling and workflow of aggregate reports through established company processes
- Monitor workflow for assigned studies and programs to ensure all deadlines are met and actively participate in project team and client meetings
- Draft, modify, and deliver safety presentations
- Begin to prepare Safety Management Plans (SMPs), Reconciliation Plans and other safety-specific plans under supervision
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