Sr Director Drug Safety (BE)

San Francisco, CA - Pharmaceutical & Biotech - Hybrid

Date Posted: 1/19/2023 9:35:48 AM

Sr Director Drug Safety
Location: San Francisco, CA
Position will be Hybrid

Responsibilities:
Safety surveillance for pharmaceutical / biological products. Lead strategy initiatives and write the key pharmacovigilance documents. Understanding and application of pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance. Apply current regulatory guidance as appropriate for safety surveillance. Author safety documents. Lead and set the strategy, in collaboration with the development medical lead of study protocols and informed consents. Proactively engage, coach, and mentor team members and colleagues. Analyze and summarize aggregate safety data and communicate these analysis and interpretation to cross-functional teams and senior management. Implement risk management strategies for assigned products.

Qualifications:
Requires MD / DO along with 2+ years of residency with patient management experience. 5-12+ years of Pharmacovigilance or Clinical Development experience in the pharmaceutical industry. Ability to present effectively, both internally and externally. Be able to analyze and guide analysis of clinical data.

Please contact Bill Emker at bemker@clarkdavis.com

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