7h ago

Director Drug Safety & Pharmacovigilance Medical Safety

Princeton, New Jersey, United States

โœจ $200k-$250k / yearest.

full-timemanager Hybridbiotech

๐Ÿ›  Tech Stack

๐Ÿ’ผ 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.

๐ŸŽฏ 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

๐Ÿ“‹ 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

โœจ Nice to Have

  • U.S. medical board certification
  • Neurology, psychiatry, or CNS therapeutic area experience
  • Experience with Argus safety database and signal detection tools

๐ŸŽ Benefits & Perks

  • ๐Ÿ–๏ธ Competitive PTO
  • ๐Ÿฅ Health insurance
  • ๐Ÿ“ˆ 401(k) matching
  • ๐Ÿข Hybrid work model

๐Ÿ“จ Hiring Process

Estimated timeline: 2-4 weeks ยท AI estimate

  1. 1Phone Screenยท 30 min
  2. 2Hiring Manager Interviewยท 60 min
  3. 3Panel Interviewยท 60 min
0 0 0