Sr. Manager/Director, Drug Safety (Pharmacovigilance)

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