Junto HLS is working directly and exclusively with Pharmacovigilance leadership, at a cutting-edge Oncology Biotech, with radical, game changing therapies, to recruit a Sr. Director/ Director of Pharmacovigilance & Risk Management.
- Responsible for the operational and strategic assessment of safety information and implementation of Risk Management (RM) activities for all compounds in development and commercialization.
- Continue to build the RM infrastructure and work cross functionally to assure achievement of optimum benefit-risk throughout the lifecycle of all applicable products
- Use strong leadership, communication and RM expertise to coordinate resources and ensure effective collaboration across Clinical Development functions and with business partner(s).
- Collaborate with PV Operations personnel and Medical Monitors to assure completeness of safety data capture in addition to medical accuracy of ICSRs
- Develop educational materials and conduct targeted training for PV and/or other clinical study team personnel to assure robust and consistent medical content of ICSRs
- Author/oversee the safety sections of regulatory documents such as the Development Safety Update Report (DSUR) and ad hoc regulatory reports as assigned
- Prepare 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
- Oversee aggregate safety data review to identify potential safety signals and act as PV co-chair of PV Committee or other such aggregate safety data review venues
- PV liaison and lead on safety-associated documents for product filing (i.e. BLA, ISS etc.)
- Serve as the PV and/or RM representative on appropriate governance bodies to assure that PV/RM decisions are communicated throughout the organization, as appropriate
PV Operational and Compliance Management:
- Partner with PV personnel to develop key procedures and infrastructure to establish a full-service Risk Management function
- May oversee all/some aspects of operational activities within the PV department including product-specific training plan for PV personnel
- Perform medical review of ICSRs
- Provide technical, hands-on authoring of study report narratives and/or vendor management activities
- Act as a resource and mentor to PV staff and contribute to the training, leadership and continuing education of staff
- 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.