Sr. Manager/Director, Drug Safety (Pharmacovigilance)
Craig Tanner & Associates
Seattle, WA · Posted October 10, 2026
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About the job
Sr. Manager/Director, Drug Safety (Pharmacovigilance) Sr. Manager/Director, Drug Safety (Pharmacovigilance) February 13th, 2020 by admin Support various pharmacovigilance and risk management/minimization activities for investigational and marketed products Responsibilities: Author and coordinate/project manage development of periodic safety reports (e.g., PSUR/PBRER, PADER, DSUR, etc) Support preparation and maintenance of Risk Management plans Contribute to development of signal detection strategy for post marketed products Support signal detection, evaluation and management according to SOPs and guidelines Contribute to preparing safety assessments reports Participate in preparing responses to safety related requests from health authorities Provide safety content review of clinical protocols, CSRs, and ICFs Requirements: Bachelor’s level degree in life sciences required; PharmD or PhD highly preferred. At least 5 years of direct Pharmacovigilance Safety Science is required. Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines. Strong knowledge of safety database (preferably ARGUS), MedDRA, and WHO Drug Strong quality focus, with a good understanding of quality systems. Excellent communicator, both oral and written, specifically medical writing skills Ability to critically analyze individual and aggregate safety data with scientific rigor Previous experience in preparing periodic safety reports and risk management plans Locations: Seattle, San Francisco, Los Angeles & San Diego Category : Uncategorized Leave a Reply Cancel reply Stay Connected... Job Search Tips Call Us | 760-598-3363 Current Openings Biotech & Pharma Positions MD Positions Consumer Goods Positions The Company | Job Search Tips | Current Openings | Employers | Contact Us © Copyright 2016 Craig Tanner & Associates | Links | Sitemap Website Design by Saba Inc. A San Diego SEO and San Diego Web Design Company Submit Resume