Associate Director Drug Safety Scientist

2 weeks ago


Cambridge, United States Pharma People Full time

About the job


Our client is a clinical stage Biotechnology company based in Massachusetts looking to bring on an Associate Director Drug Safety Scientists. This role is a safety expert position contributing to the global safety strategy and overall safety profile for the assigned products throughout lifecycle as well as their post-marketed products.


Responsibility :


  • for implementing risk management strategies for assigned product.
  • the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for assigned products , communicate these analysis and interpretation to cross-functional teams and senior management.
  • set the strategy and when appropriate write the key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses.
  • current regulatory guidance as appropriate for safety surveillance and authorship of safety documents.
  • collaborate with drug safety physicians and cross-functional teams for safety assessment (e.g. review of AEs; safety reports; trial protocols; clinical study reports), ongoing surveillance, and related communication around assigned products.
  • management and training for new staff on department practices and TA knowledge.

Requirements


  • MD, MSN, RN required.
  • requirement: 6 years' experience in drug safety/pharmacovigilance within pharmaceutical industry (Biotechnology experience is preferred)
  • with global PV regulatory environment (regulations, initiatives, standards, GVP)
  • of Electronic databases (Argus, Arisg Safety) as well as signalling tools (Empirica, Spotfire)
  • collaboratively and lead cross-functional teams.


This role can be remote, however, there is preference to hybrid working in their office based in Cambridge, MA



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