Director, Drug Safety Operations

South San Francisco, California, United States
Aug 09, 2019
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time

This position will report to Senior Vice President Development Operations. and will provide leadership, direction, and operational oversight of global clinical drug safety activities for the company's phase I-IV studies.

  • Responsible for Adherence to Pharmacovigilance global documentation and reporting requirements.
  • Direct and Manage the outsourced pharmacovigilance function
  • Oversight and review of the vendor's processing of Individual Case Safety Reports (ICSRs), including adherence to the Safety Management and Operational Plan
  • Oversight and triage of internal medical and team review of SAEs for all investigational drugs in the Principia clinical pipeline
  • Oversight of aggregate global pharmacovigilance reporting activities and adherence to global reporting requirements
  • Ensure compliance with US and international regulations for safety reporting
  • Oversight of safety data reconciliation for safety and clinical databases.
  • Oversight of Principia's, drug safety SOPs and ongoing review of drug safety data quality and pharmacovigilance system.
  • Oversight of Principia's Pharmacovigilance Master File set-up and implementation in conjunction with marketing authorization holder status
  • Oversight and review of safety-related plans with CROs and partners.
  • Train internal staff and external vendors on drug safety policies and procedures.
  • Serve as an ad-hoc member of the cross-functional clinical Study Execution Teams
  • Develops standardized risk sections of informed consent forms in conjunction with the internal medical team.
  • Review of Investigator Brochure and protocol safety risk/benefit sections
  • Authoring of standardized risk language for patient informed consent documents
  • Oversight of quarterly program level safety review meeting content and documentation

  • Strong working knowledge of drug safety databases (preferably ArisG) and an ability to generate safety reports.
  • Demonstrated experience in core and technical aspects of initiating and managing drug safety for phase 1-4 clinical trials and post-marketing safety reporting requirements.
  • Demonstrated experience in management of CROs and/or outsourced drug safety vendors
  • Demonstrated experience in US and Global Regulations and Good Pharmacovigilance Practices (GVP) and Guidance's (PDFUA, ICH-GCP, FDA-CFR )
  • Demonstrated experience in authoring and maintaining drug safety policies and SOPs
  • Strong computer skills

  • Degree in nursing, pharmacy or minimum of MS in a life-science
  • Minimum 10 years relevant global pharmaceutical drug safety oversight and management experience.