Drug Safety Specialist Resume Sample
Arjun Macejkovic
658 Franecki Garden,
Chicago,
IL
+1 (555) 386 9371
Work Experience
Drug Safety Specialist
05/2018
-
PRESENT
San Francisco, CA
- Assists with the workload of other Safety Specialists within the department
- Liaises with Manager or designee with regard to resources, timelines, and issues with quality; reorganizes daily workload based on priority; proactively communicates to management new issues; offers solutions and reports availability to take on new assignments
- Trains new staff; acts as the primary resource for other Safety Specialists with regards to answering questions,sharing knowledge and assisting in resolving problems; provides technical support
- Ensures that all aspects of the Company’s safety data collection and processing are consistent with currentindustry practices and meet all pertinent domestic and international regulatory requirements; ensures correct study setup and closure including proper documentation and archival
- Provides support to senior departmental management surrounding business development activities, budget, and proposal input, etc., as required
- Provides input to senior departmental management regarding ways to ensure adherence to relevant procedures/regulations, ways to improve work efficiency and maintain customer satisfaction
- Maintains knowledge of ongoing projects and disease-related terminology
- Planning and distribution of the periodic safety reports (DSUR, PSUR, 6 monthly line listings) and reporting of SAEs to competent authorities or partners
- Prepare and communicate compliance reports (Monthly, Quarterly and yearly)
Senior Drug Safety Specialist
04/2011
-
03/2018
Los Angeles, CA
- Prepare procedures, SOPs, guidelines and other standard materials required for project
- Coordinate dissemination of specific regulatory intelligence to appropriate individuals
- Record and communicate global regulatory requirements
- Support the preparation of proposals
- Ensure overall compliance with ICH, EMEA and FDA guidelines
- Organization and management of pharmacovigilance operations 2. CPO Accreditation on AE reporting compliance 3. Quality and timely reporting of KPI and safety reports/updates 4. Results of audits/inspections 5. Customer feedback
- Graduate or post graduate in pharmacy/health sciences
Drug Safety Specialist, Novartis, Norway
02/2009
-
03/2011
Houston, TX
- Pharmaceutical industry or contract research organisation experience working within pharmacovigilance
- Manage own workload and interact well in a team environment
- Assist in preparation of annual and other periodic safety reports
- Conduct periodic reviews of relevant medical and scientific literature, as needed
- Prepare and/or review safety management plans and other documentation (includes PV agreements with partners) in support of Halozyme's clinical trials
- Assist with the development (and improvement) of drug safety standard operating procedures (SOPs) and processes
- Maintain Halozyme safety case files
- Ensure that clinical and/or post marketing adverse event reports are received, tracked, evaluated, processed/imported, and distributed in an efficient and timely manner and in compliance with regulations and Halozyme SOPs
Education
Kaplan University - Lincoln Campus
2003 - 2008
Science's Degree in Nursing
Professional Skills
- Excellent time management skills to manage multiple workload
- Strong skills in project management, risk management, problem-solving and communication effectiveness
- Proven ability to work effectively on multiple projects under tight timelines, maintain flexibility, adapt and prioritize as needed
- Good communication skills, including good English written and spoken
- Good problem solving and technical skills
- Experience and skill with medical writing an advantage
- Synthetic and analytic skills as well as accuracy in daily work required
How to write Drug Safety Specialist Resume
Drug Safety Specialist role is responsible for medical, database, negotiation, computer, health, english, interpersonal, research, international, software.
To write great resume for drug safety specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Drug Safety Specialist Resume
The section contact information is important in your drug safety specialist 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 Specialist Resume
The section work experience is an essential part of your drug safety specialist 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 specialist 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 specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Drug Safety Specialist resume experience can include:
- Assist with tracking the review literature articles and abstracts to identify valid ICSRs
- MedDRA coding experience highly desirable
- Experience writing SOPs and other procedural documents
- Experience in working in drug development and/or healthcare environment
- Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines
- Build strong relationships with external parties, including CROs and study site staff
Education on a Drug Safety Specialist Resume
Make sure to make education a priority on your drug safety specialist 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 specialist 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 Specialist Resume
When listing skills on your drug safety specialist 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 specialist skills:
- Good organizational, planning and project management skills
- Pharmaceutical experience with 2 years safety surveillance experience
- Working knowledge of 21 CFR Part 11 and computer validation
- Test configurations in the safety database, e.g., new study configurations, executing User Acceptance Testing (UAT) as part of system validation
- Experience writing deviation memos and performing late case investigations
- Fluent English (prioritized writing, reading)
List of Typical Experience For a Drug Safety Specialist Resume
1
Experience For Senior Drug Safety Specialist Resume
- Familiarity with general medical and pharmacology principals with excellent written and verbal communication skills
- Accurately process data entry, code/map data, and write case narratives / other medical writing skills are needed
- Work effectively with remote team members
- Maintain andtrack all serious adverse events reported from sponsored clinical trials for case processing relative to their priorities and submission deadlines
- Strong understanding of clinical trial data management, databases, case report forms (CRF's) and ICH/GCP guidelines
- Experience in drug safety / Development or closely related areas of responsibility
- Hands on, relevant experience with controlled documents/scientific documents/safety records
- Completes AE/SAE reconciliation prior to clinical trial database closure
2
Experience For Medical Information & Drug Safety Specialist Resume
- Pharmacovigilance experience is required
- Demonstrated ability to work independently while in a fast pace, complex and dynamic team environment
- Review literature articles and abstracts to identify valid ICSRs
- Build strong relationships with outside vendors, CROs, partner companies as well internal personnel across departments
- Effective interactions and diplomacy
- Developing and improving drug safety standard operating procedures (SOPs) and processes
- Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerized
3
Experience For Drug Safety Specialist, Novartis, Norway Resume
- Liaises with internal and external stakeholders to ensure appropriate review, monitoring and compliance regarding adverse event reporting for defined programs
- Assists with providing safety support and training for clinical, monitoring, and clinical site personnel as needed
- Notify drug safety staff of issuesrelated to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines
- In conjunction with the clinical study team, providing periodic reviews of emerging safety data
- Responsible for conducting adverse event training for internal and external stakeholders
- Assists with implementing safety surveillance processes and establishing appropriate SOPs
4
Experience For Drug Safety Specialist, Global Drug Safety Resume
- Acts as DSR Deputy: functional (in terms of responsibility for PV system) and operational (in terms of managing the DS&E Team)
- Accountable for accurate data capture of adverse event reports, including literature articles, associated with Company products into the global safety database
- Literature database access and searching
- Create documents using Microsoft programs and automated software programs
- Manage the project timelines and deliverables working within a specified timeframe
- Proficiency in word processing programs
- Carry out case processing activities
- Review case criteria to determine appropriate workflow for case processing
5
Experience For Drug Safety Specialist Resume
- Determine and perform appropriate case follow-up, including generation of follow-up requests
- Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation
- Processes all types of adverse event reports utilizing the ARISg safety database
- Develops guidelines and insures the uniform and timely processing of adverse event reports
- Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
6
Experience For Senior Drug Safety Specialist Resume
- Performs quality related activities related to Field Alert Reporting, and CAPA
- Performs authoring of aggregate reports as needed
- Performs MedDRA coding and maintains the MedDRA dictionary as needed
- Participates in signaling activities as needed
- Organize, categorize and archive all existing and new human health, environmental and occupational safety assessment documents
- Competence using Argus safety database
- Create major modifications following Medical Review
- Contribute to the orientation and training of staff as needed
- Conduct follow-up with clinical sites and/or reporting parties to obtain all pertinent adverse event information
7
Experience For Medical Information & Drug Safety Specialist Resume
- Initiate/review processes regarding workflow
- Identification and resolution of case processing issues as they arise
- Initial triage of incoming reports
- Adherence to global regulatory regulations and reporting timelinesfor all expedited serious adverse events
- Executes case assessment (review events, determine expectedness, review/update drug and medical term coding, determine causality)
- Ensures individual case reports are accurate, complete and timely for regulatory reporting purposes
- Support the identification of case corrections and creation of updates in the safety database following medical review
- Manages to phone calls directed to drug safety regarding AE reports, and general queries
- Serve as pharmacovigilance resource during inspections and audits
8
Experience For Drug Safety Specialist, Novartis, Norway Resume
- Contribute to the maintenance of a regulatory reportability matrix and other supporting documentation
- Identify and respond appropriately to new safety reports to protect patients and maintain full compliance with regulatory requirements
- Provide as-needed safety support for Investigator-initiated trials with Halozyme products
- Work independently or as part of a team and without close supervision
- Prepares SOP’s and work practice documents
9
Experience For Drug Safety Specialist, Global Drug Safety Resume
- Provide safety related information to global teams for the preparation of Aggregate Reports, when necessary
- Review and approve the safety sections/wording and processes in local commercial agreements to ensure appropriate training and reporting processes in accordance with global Roche and local regulatory authority requirements
- Responsible for accurate data capture into the safety database and submission to KIDS of adverse event reports, including literature articles, associated with Company products in accordance with internal processes and local regulatory requirements
- Manage drug safety activities in a timely manner according to global processes and local regulatory requirements
- Determine and/or confirm if the case meets expedited reporting criteria. Ensure adverse event reporting compliance with AMAG SOP’s, SDEA timeframes, FDA, EMA, ICH and other regulatory requirements
- Screen medical and scientific literature via journal articles for safety review based on select criteria
- Follow process steps to select literature
10
Experience For Drug Safety Specialist Resume
- Confer and consult with project team members to obtain deliver the pharmacovigilance contribution
- General knowledge of medical scientific literature journal articles (e.g., function, types, use, etc.)
- General knowledge of pharmaceutical, pharmacovigilance, safety processes desired
- Attention to detail and timeline adherence
- Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit case narrative
List of Typical Skills For a Drug Safety Specialist Resume
1
Skills For Senior Drug Safety Specialist Resume
- Strong organizational and detail-oriented skills, including the ability to prioritize independently with minimal supervision
- Experience in PV, at least 1-2 years of experience in safety reporting
- Effectively interface with other line functions within Halozyme (e.g., Clinical Development, Regulatory Affairs, Data Management, Finance, etc.)
- Relevant experience in the Industry; Drug Safety experience required
- Effectively interface with other line functions within Halozyme (e.g., Clinical Operations, Regulatory Affairs, Data Management, etc.)
- Thorough understanding of PV regulations and has experience of working with EudraVigilance
- Clinical experience in a medical setting
- Experience in drug safety serving in a PV Scientist or similar role
- Build strong relationships with external parties, including CROs
2
Skills For Medical Information & Drug Safety Specialist Resume
- Drug safety experience – clinical or postmarketing
- Previous experience (2-5 years) in a Drug Safety Department or Clinical Operations within a large pharmaceutical company appreciated
- Experience in drug safety, pharmacovigilance area
- Drug safety experience in a biotechnology or pharmaceutical company
- Clinical trial experience in the pharmaceutical/biotechnology industry
- Relevant medical, scientific/clinical or pharmaceutical experience
- Experience in PVG essential
3
Skills For Drug Safety Specialist, Novartis, Norway Resume
- Nominal years of Safety and PVG experience
- Relevant medical, scientific/clinical, or pharmaceutical experience
- Performing and tracking the completion of electronic safety submissions and addressing instances of technical failure
- Collaborating and supporting APAC Hub in the transition of applicable activities together with overseeing Hub performance in those transited
- Working knowledge of global safety reporting requirements
4
Skills For Drug Safety Specialist, Global Drug Safety Resume
- Monitoring and problem solving of E2B exchange issues as they arise
- Authoring of SOPs and training guides applicable to above processes
- Ensuring that individual Adverse Event Case Reports are evaluated against regulatory reporting requirements
- Understanding of Microsoft office applications, specifically Excel and Word
- Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised
- Reading of journal articles
- Documenting the decision and judgement for ICSRs
- Performing complete data entry of serious adverse events received from clinical trials
- Providing data to partners to ensure compliance with Pharmacovigilance Agreements and in response to ad hoc requests
5
Skills For Drug Safety Specialist Resume
- Assisting in the preparation of annual and other periodic safety reports
- Assisting with Investigator's Brochure and label revisions
- Coordinating the reconciliation of data from safety reports and the clinical trial database
- Case processing – receiving/acknowledging receipt, triaging, analyzing and reporting safety information for investigational and marketed products
- Case processing - acknowledging receipt, data entry, reporting, querying, and follow-up of safety information for investigational and marketed products
- Proactively liaising with program owners and providing guidance and information on the requirements for collecting adverse event (AE) reports
6
Skills For Senior Drug Safety Specialist Resume
- Proficient in all aspects of case processing, including case assessment (seriousness,
- At least one to two and half years of working in drug safety/pharmacovigilance, including
- At least three or more years working in drug safety/pharmacovigilance, including
- To triage incoming AE reports to ensure their correct handling by Celgene
- Perform E2B importing and monitoring in Argus
7
Skills For Medical Information & Drug Safety Specialist Resume
- Contribute to the development and writing of industry standard operating procedures and processes for pharmacovigilance activities
- Assist with monitoring of compliance (regulatory reporting)
- Supports the management of case processing deadlines for aggregate safety reporting
- Contribute to the hiring, orientation and training and development of staff as needed
- Maintain compliance with all required training and standard operating procedures
8
Skills For Drug Safety Specialist, Novartis, Norway Resume
- Receive, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature
- Management of case report: review safety information from all sources, triage, case processing, following up and submission
- Management of Pharmacovigilance (PV) training for Affiliate personnel and ensure the PV training compliance rate aligned with global requirement
- Information sharing with other departments, e.g., Drug Safety, Medical Information, Sales, Medical Affairs, Marketing
- Management of Periodic Benefit and Risk Evaluation Report (PBRER) including tracking receipt, submission and record (as applicable)
- Understands, interprets medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology)
- Assist in developing Risk Management Plans and allied activities
- Review of various Health Authority websites for safety triggers and taking appropriate action
9
Skills For Drug Safety Specialist, Global Drug Safety Resume
- Safety related contribution in CCDS/RSI development, review and updating
- Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
- Achieve personal objectives while meeting departmental standards of performance
- Proficient in data entry and electronic reporting in global drug safety databases
- Clinical Trial and Post-marketing exp
- To manage safety data within Celgene’s central safety database covering both pre- and post-market activities
- To ensure compliance with regulatory reporting requirements
- Accountable for submission of ICSRs to regulatory authority, ensuring compliance with internal SOPs and local regulatory requirement and timeline
10
Skills For Drug Safety Specialist Resume
- Conduct the assessment of all serious individual adverse event case reports stemming from pre-clinical studies, post-marketed and literature sources
- Perform data entry of post-marketing and clinical ICSRs into the safety database
- Assist with gathering safety data for inclusion in aggregate safety reports
- Assist with investigation, documentation and tracking of Drug Safety deviations/CAPAs
- Assist with management of Halozyme Drug Safety personnel training requirements
- Provide training to CRO/vendor personnel, as needed
List of Typical Responsibilities For a Drug Safety Specialist Resume
1
Responsibilities For Senior Drug Safety Specialist Resume
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
- Proven hands-on experience with safety databases
- Able to build strong relationships with outside vendors, CROs, partner companies as well internal personnel across departments
- Performs pharmaceutical complaint Adverse Drug Experience and Drug Quality determinations and determines the level of investigation required
- Drug safety knowledge and experience
- ARISg experience required
2
Responsibilities For Medical Information & Drug Safety Specialist Resume
- Determine reportability of scheduled reports , ensuring adherence to regulatory requirements
- Support the environmental fate and effects testing and risk assessment database management
- Perform SAE and AE/PC reconciliation activities, ensuring completion and closure of cases are performed in a timely fashion
- Identify missing or discrepant information and perform active case follow-up via verbal or written contact
- Consistently apply regulatory requirements and Pfizer policies
- Participate, as appropriate, in local, internal and external safety activities
- Ensuring that clinical and postmarketing adverse event reports for Halozyme and partnered programs are received, tracked, evaluated, processed, and distributed in an efficient and timely manner and in compliance with regulations and Halozyme SOPs
- Maintenance of Halozyme safety case files
3
Responsibilities For Drug Safety Specialist, Novartis, Norway Resume
- Provides medical assessment on all cases for seriousness; conducts quality review of cases; conducts follow-up on cases; communicates responses to queries related to drug safety
- Reviews, updates / creates local process documents as required
- Reviews Canadian journals and other data / information sources for potential adverse events
- Ensuring that clinical and post-marketing adverse event reports for client and partnered programs are received, tracked, evaluated, processed, and distributed in an efficient and timely manner and in compliance with regulations and client SOPs
- Maintenance of clients safety case files
4
Responsibilities For Drug Safety Specialist, Global Drug Safety Resume
- Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAE’s are complete prior to database closure
- Process and distributes clinical study SAE reports as per the company SOPs
- Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company’s SOP’s
- Assists with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested
- Microsoft Windows XP, Microsoft Office Suite, Industry recognized safety database (e.g. ARISg or equivalent)
- Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAE?s are complete prior to database closure
- Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the companies SOPs
- Ensures compliance with standard operating procedures, Food and Drug Administration and ICH guidelines and regulations, and global regulations for the reporting of adverse events to regulatory agencies
- Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary
5
Responsibilities For Drug Safety Specialist Resume
- Performing complete data entry of serious adverse events received from clinical trials, according to the Client workflow processes and standard operating procedures
- Draft appropriate initial queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior Drug Safety person
- Communicate or notify Client’s drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines
- Maintain and track all serious adverse events reported from Client sponsored clinical trials for case processing relative to their priorities and submission deadlines
- Adherence to global regulatory regulations and reporting timelines for all expedited serious adverse events
- Support Drug Safety Department initiatives on ad hoc (as needed) basis
- Maintain or track annual and/or periodic Pharmacovigilance regulatory submissions in USA and globally
- Ensure compliance with Client’s SOPs
- Develops guidelines and insures the uniform and timely processing of adverse event reports. Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
6
Responsibilities For Senior Drug Safety Specialist Resume
- Develops and prepares reports for company management as well as external regulatory agencies. Assists in the preparation of safety updates for investigational new drug and new drug applications, investigator communications, product labeling/package inserts and other reports as necessary
- Performing complete data entry of serious adverse events received from clinical trials, according to the company’s workflow processes and standard operating procedures
- Draft appropriate initial queries for outstanding information or incomplete data and communicate the queries to study site personnel following review and approval of the queries by a senior employee in drug safety
- Communicate or notify drug safety staff of issues related to case processing/coding, safety database and/or any other issues that impact case processing quality or timelines
- Maintain and track all serious adverse events reported from company sponsored clinical trials for case processing relative to their priorities and submission deadlines
7
Responsibilities For Medical Information & Drug Safety Specialist Resume
- Perform QC of Individual Case Safety Reports (ICSRs) from clinical trial and post marketing sources
- Ensure compliance with company SOPs
- Facilitate the Triage and Medical Review of ICSRs, as well as the generation of the analysis of similar events
- Contribute to the development of department work instructions and SOPs
- Maintain ICSR case files and related safety documentation
- Monitor CRO activities, ensuring appropriate case processing and regulatory reporting based on Halozyme case processing conventions, global regulatory requirements and Drug Safety best practices
- Complete adverse event reconciliation for ICSRs received from partners
- Maintain safety documentation in an audit-ready state and support audits/inspections
- Manage the drug safety mailbox
8
Responsibilities For Drug Safety Specialist, Novartis, Norway Resume
- Contribute to the development of safety management plans and support adherence to the plans
- Contribute to quality improvement and business optimization initiatives in Drug Safety Operations
- Collaborate with Drug Safety Operations, Safety Surveillance and Safety Informatics teams to configure and generate reports/line listings from the safety database
- Assist with the maintenance of pharmacovigilance agreements
- Utilizes full understanding of drug safety to conduct complete clinical reviews of all domestic and foreign adverse event reports received for all Fresenius Medical Care products. Resolves a wide range of issues in creative ways
- Serves as a PV Safety contact to other departments and Fresenius Medical Care-North America, Renal Therapies Group, LLC, licensing partners
- Provides medical review as needed
9
Responsibilities For Drug Safety Specialist, Global Drug Safety Resume
- Generate and maintain the human health, environmental and occupational safety assessment tracking database to ensure the consistency, transparency and efficiency of the PCARA process
- Demonstrated ability to work effectively for prompt results delivery in a fast-paced environment
- Review existing safety assessment documents to extract critical chemical toxicology information
- Based on the existing toxicological risk assessment reports, generate the chemical toxicological profile and summary database to support prospective chemical safety assessment
- Under supervision and instruction, maintain and update the chemical point of departure and human safety threshold database
10
Responsibilities For Drug Safety Specialist Resume
- Build the pharmaceuticals database to assist safety assessment
- Assumes other drug safety assessment responsibilities as needed
- The scope of the responsibilities is to support the company's business
- High capability to deal with complexity of projects and identify solutions to support business
- Be able to work independently as well as with a teamwork spirit
- Safety data and utilize clinical judgment in coding of verbatim adverse events, medical history and medications. Ability to synthesize complex clinical information into accurate and complete reports
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