Sr. Manager/Director, Drug Safety (Pharmacovigilance)

Sr. Manager/Director, Drug Safety (Pharmacovigilance)

February 13th, 2020 by

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

Stay Connected...
find us on linkedin
friend us on facebook
follow us on twitter
subscribe to our rss