Director, Drug Safety Operations

Location
South San Francisco, California, United States
Posted
Aug 09, 2019
Ref
59
Hotbed
Biotech Bay
Required Education
Masters Degree/MBA
Position Type
Full time
Responsibilities:

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

Qualifications:
  • 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


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