Edison-New Brunswick Metro Area, NJ
- Advanced degree (MD, Ph.D., Pharm.D., BSN or MSN/ R.N.).
- At least 5 years or more of relevant pharmacovigilance experience.
- Proficiency in current safety systems (Argus, ArisG or similar).
- Experience in analyzing, interpreting, and presenting scientific and medical data in verbal and written format.
- Ability to work effectively independently and collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues.
- Strong organizational, project management and leadership skills.
- Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations.
- Ideally looking for a combination of experience including experience in aggregate safety reports and safety signal management.
Essential Skills Needed:
- Assist the PV Safety Lead in safety surveillance activities for assigned product(s) during all phases of the product life-cycle (includes both investigational and marketed products).
- Oversee the aggregate reports production including strategy, review and finalization of aggregate safety reports for assigned products such as PADERs, PBRERs, and DSURs, and signal management.
- Provide safety content for REMS assessment reports and support RMP updates. (as applicable).
- Coordinate Safety Review Team meetings (including scheduling, preparation of reports, and documentation of meeting results).
- Support safety related activities for clinical trials i.e. review of protocols, ICFs, statistical analysis plans, safety content of Investigator Brochure, and clinical study reports.
- Provide safety content for regulatory filings including review of the safety and benefit risk sections, and ensure consistency across documents and support response preparation.
- Support the signal management process (i.e., signal detection, tracking, leading review meetings) for assigned product(s) and evaluate safety data and signals as part of ongoing pharmacovigilance activities.
- Coordinate and author responses to regulatory agencies or responses to inquiries from internal or external stakeholders in collaboration with the PV Safety Lead.
- Facilitate inspection readiness activities, if applicable.