Sr Dir, Post Auth Saf Studies (GK)

San Francisco, CA - Pharmaceutical & Biotech - Hybrid

Date Posted: 12/1/2022 4:38:48 PM

Senior Director, Post Authorization Safety Studies
San Francisco, CA (Hybrid)

Responsibilities:
Safety surveillance for post-market / Phase 4 pharmaceutical / biological products.
Lead strategy initiatives and write the key pharmacovigilance documents. Apply current regulatory guidance as appropriate for safety surveillance of marketed products. 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:
MD / DO required. 2+ years of residency with patient management experience preferred. 8+ years of Pharmacovigilance or Clinical Development experience in the pharmaceutical industry, strongly prefer Post-authorization study experience. Ability to present effectively, both internally and externally. Be able to analyze and guide analysis of clinical data.

Please contact Greg Kane at gkane@clarkdavis.com

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