Director/ Associate Director, Pharmacovigilance & Risk Management

Junto HLS is working directly and exclusively with Pharmacovigilance leadership, at a cutting-edge Oncology Biotech, with radical, game changing therapies, to recruit a Director/ Associate Director, Pharmacovigilance & Risk Management.

Position Overview:

  • Conduct safety signal work-ups and prepare internal and external reports/presentations relating to signal detection in preparation for safety surveillance meetings
  • Perform comprehensive medical review of ICSRs
  • Collaborate with PV Ops personnel and the Medical Monitor function to assure completeness of safety data capture in addition to medical accuracy of ICSRs
  • Prepare and track RM deliverables including applicable aggregate reports and other clinical/regulatory documents/queries with support from Head of RM
  • Support Head of RM in maintenance of Reference Safety Information (RSI)
  • Work with PV Compliance to appropriately maintain and version Risk Management owned documents such as signal management documents, RSI, safety section templates for clinical documents, etc.
  • Work closely with Head of RM, Regulatory Affairs and affected business partners to assist in drafting responses to questions from global health authorities
  • Serve as the RM representative at appropriate team venues to assure that RM decisions are communicated throughout the organization, as appropriate
  • Support the implementation of RM infrastructure including development and revision of procedural documents and tools associated with signal detection and risk communication
  • Support preparation of or review safety-related sections and associated documents for clinical and regulatory documents such as clinical study reports, investigator brochures, study protocols, company core /safety labeling documents
  • Collaborate with Head of RM to develop educational materials and conduct targeted training for PV personnel to assure robust and consistent medical content of ICSRs
  • Collaborate with business partners to implement appropriate Risk Management strategies
  • Maintain knowledge and advance the paradigm of Risk Management through internal and external influencing activities (i.e. seminar presentations, participation in regulatory forums, publications), as applicable
  • Champion the use of epidemiologic tools to better aid the understanding of observed adverse event rates in key populations

Location:

San Francisco, CA or Seattle, WA

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.