Associate Medical Safety Director- Sponsor Dedicated (Home-Based)
Core
Associate Medical Safety Director providing pharmacovigilance expertise, signal detection, and benefit-risk evaluation for product portfolios.
Role type
Associate Medical Safety Director (Pharmacovigilance)
Builds
Periodic safety reports, risk management plans, and safety summaries for clinical and post-marketing drug portfolios.
Domain
Life Sciences / Pharmacovigilance
Required skills
Medical degree, clinical practice experience, signal detection, aggregate report analysis, risk management, regulatory knowledge (GCP, clinical trials), adverse event adjudication, benefit-risk evaluation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead signal detection and analysis; Provide medical review for IND Annual Reports, EU/US Periodic Safety Reports; Contribute to Risk Management Plans and Benefit-Risk Evaluations; Review and update drug labels; Adjudicate trial-related Adverse Events and post-marketing ADRs; Represent safety findings in stakeholder meetings.
Seniority
Associate Director, hands-on IC