2h ago
Sr. Medical Director, Pharmacovigilance
Remote
full-timesenior Remotebiotechnology
Tech Stack
Description
You will lead medical safety evaluation and benefit-risk assessment for products throughout their lifecycle. You will oversee cross-functional safety teams, conduct signal detection and risk management, and ensure regulatory compliance. Your work directly impacts patient well-being and advances drug development for central nervous system disorders.
Requirements
- MD or equivalent with 3-5 years of relevant clinical experience
- Minimum 10 years' industry experience in Drug safety/Pharmacovigilance
- Experience in safety data analysis, signal management, and benefit-risk evaluation
- Working knowledge of safety databases (Argus, ArisG/LifeSphere Safety, or similar)
- Board Certified/Board Eligible in Neurology or psychiatry preferred
Responsibilities
- Lead product safety surveillance and benefit-risk assessment across product lifecycle
- Conduct signal detection, evaluation, and management of safety data from various sources
- Oversee Risk Management documents (DRMPs, RMPs, REMS) and regulatory responses
- Provide medical review of adverse event reports and safety content in regulatory documents
- Coach, mentor, and manage safety scientists supporting surveillance activities
0 views 0 saves 0 applications