Pharmacovigilance Medical Director
Northern, New Jersey
We have partnered with a rapidly expanding pharma company who is seeking a Pharmacovigilance Medical Director to join their team. This company has one drug approved in the US and is looking to expand on that success with over 25 other indications in pipeline globally across a wide range of therapeutic areas. If you are looking to get in with a stable & growing biopharmaceutical company that prides itself on its patient-focused approach than don't hesitate to apply to learn more!
The Pharmacovigilance Medical Director will have the following responsibilities:
- Participates in FDA or other health authority safety interactions/responses with support from his/her manager.
- Has full accountability for all aspects of the global drug safety function, including development/delivery of a quality Pharmacovigilance system for assigned products/activities. Is the primary safety representative between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, external experts, and CROs) on product safety related issues.
- Leads safety signal detection activities and global cross functional safety teams, with appropriate communication/escalation. Oversees/conducts signal tracking for products according to regulatory requirements and corporate business strategy.
- Completes/reviews medical assessments of safety data [Periodic Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents; as appropriate) and ensures the benefit/risk information is accurate.
- Oversees development and preparation of Risk Management Actions Plans for regulatory filings.
The ideal candidate will have the following skill-set:
- Minimum of 5+ years' experience
- Strong knowledge FDA and other international regulations
- Excellent communication skills
- Experience with Pharmacovigilance Aggregate Reports and Signal Detection
- Excellent Salary
- Competitive bonus & LTI
- Exceptional benefits