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.
- 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
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.