Drug Safety Senior Specialist
- Coordinate and document ongoing safety surveillance activities with the safety physician. Activities will include safety data review, signal validations, signal evaluations
- Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks.
- Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activities
- In conjunction with the safety physician, prepare materials for routine and ad hoc Safety Governance meetings (product- and leadership-level meetings).
- Coordinate responses for ad hoc safety queries (eg, health authority requests, NISS, or health hazard evaluations) in conjunction with the safety physician and cross functional team members, as needed.
- Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization.
- Represent safety (with safety physician) and cross functional product meetings
- Support activities relevant to investigational program including (but not limited to):
- Routine/ad hoc updates to safety content of Investigator Brochure (IB), safety content of protocols, CRFs, ICFs
- Routine DSMB presentations
- Ongoing data review, including lab and AE data review
- Maintain strong working knowledge of relevant regulations associated with the above activities.
- Contributes to initiatives for process improvement and cross-product process consistency.
- Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist role.
- Demonstrated experience in analysis and interpretation of medical and scientific data and excellent verbal and written skills.
- Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
- Demonstrated ability to prioritize multiple assignments and proactively identify solutions, as needed
- Strong organizational, project management and leadership skills: Leads and conducts (independently and/or collaboratively) all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
- Oversees and mentors less experienced PV Scientist staff.
- Demonstrated clinical judgment to interpret case information.
- Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts.
- Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety System
- Rate: $73.00/hour
- W2 Contract
- Worksite Location: Waltham, MA
- Hybrid
- 6 month contract
- Excellent medical health, dental & vision insurance at 60 days
- Our employees may choose to participate in a 403(b) retirement plan
- Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
- We pay weekly through direct deposit
- In business since 1994 and thousands of job placements
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