Associate Director, Safety Science
Location: South San Francisco, CA
As Associate Director, Safety Science, you will lead signal detection efforts, conduct medical reviews of ICSRs, and contribute to the development of aggregate safety reports and risk management plans.
Key Responsibilities:
-Medical review of pre- and post-marketing ICSRs (seriousness, causality, expectedness, MedDRA coding)
-Signal detection and evaluation in collaboration with cross-functional teams
-Preparation of aggregate reports (PSUR, DSUR, PADER, etc.)
-Participation in Safety Management Teams and contribution to RMPs, protocols, IBs, and clinical study reports
Qualifications:
-Clinical or scientific degree (BSN, RN, PharmD, MD, DO, or equivalent)
-Experience in pharmacovigilance or drug safety
-Proficiency with safety databases (e.g., Argus)
-Strong understanding of global safety regulations and ICSR handling
If you’re passionate about drug safety and ready to make an impact, let's connect!!
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