7h ago
Director Drug Safety & Pharmacovigilance Medical Safety
Princeton, New Jersey, United States
โจ $200k-$250k / yearest.
full-timemanager Hybridbiotech
๐ Tech Stack
๐ผ About This Role
You'll serve as the primary medical safety resource for assigned products across Acadia's portfolio, performing medical evaluation of safety data and signal detection. You'll collaborate cross-functionally on safety governance and author regulatory documents like DSURs and PBRERs. This role offers hybrid work in Princeton, NJ with significant impact on neurological and rare disease treatments.
๐ฏ What You'll Do
- Perform medical evaluation of aggregate safety data for assigned products
- Author Analysis of Similar Events (AOSE) and individual case narratives
- Provide medical oversight for clinical study safety activities
- Contribute medical input to safety governance bodies and regulatory submissions
๐ Requirements
- MD (Doctor of Medicine) or equivalent medical degree
- 6-7 years relevant drug safety/pharmacovigilance experience
- Expertise in safety signal management and aggregate data review
- Advanced knowledge of FDA, EU, and ICH pharmacovigilance regulations
โจ Nice to Have
- U.S. medical board certification
- Neurology, psychiatry, or CNS therapeutic area experience
- Experience with Argus safety database and signal detection tools
๐ Benefits & Perks
- ๐๏ธ Competitive PTO
- ๐ฅ Health insurance
- ๐ 401(k) matching
- ๐ข Hybrid work model
๐จ Hiring Process
Estimated timeline: 2-4 weeks ยท AI estimate
- 1Phone Screenยท 30 min
- 2Hiring Manager Interviewยท 60 min
- 3Panel Interviewยท 60 min
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