Job Description :

Location: United States - California - Brisbane

The Director of Pharmacovigilance (PV) is responsible for strategic leadership and medical oversight of PV (BPV) activities in collaboration with the EU Qualified Person for PV (EU QPPV), BPV colleagues, and applicable cross-functional specialists, with special focus on identification, evaluation and management of safety risks throughout products lifecycle.

Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting. Assist in follow-up of important ICSRs to ensure relevant information is sought. Collaborate with Clinical Science, Medical Affairs, PV colleagues and applicable functional specialists to identify, evaluate and manage safety signals. Participate in the development of safety surveillance and risk management plans for drug development programs. Contribute to the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual ReportServe as Safety Management Team Leader and liaise with clinical study/project teams, Clinical Operations, Medical Affairs, Biostatistics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees and other entities as needed. Provide safety advice and inform Pharmacovigilance senior management as appropriate. Participate in the preparation and revision of company product labeling and RMP as appropriate. Collaborate with Medical Directors in both Clinical Development and Medical Affairs to provide expertise in both US and ex-US post-marketing safety surveillance requirements (e.g., registries Review and advise on safety/medical information in advertising and promotional materials as needed. Help prepare and review safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.

Required Skills:
Minimum 5 years of experience in PV with specific drug safety operational experience. Excellent medical knowledge with the ability to interpret, synthesize and communicate complex medical/pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs. Experience reviewing cumulative safety data. Strong working knowledge of US and ex-US PV requirements (e.g., US Code of Federal regulations; European Union GVP legislation; and ICH Guidelines Experience with pre- and post-marketing ICSR processing and aggregate safety reporting. Knowledge of MedDRA terminology and its application. Experience in the preparation of PSURs, Pharmacovigilance Plans, Risk Management Plans, and Reference Safety Information. Experience in safety issue/signal management. Thorough understanding of the drug development process and context applicable to safety surveillance. Excellent verbal and written communication skills, including formal presentations. Sound organizational skills with the ability to prioritize tasks. Excellent interpersonal, team management and leadership skills. Proficiency in Word, Excel, and safety databases.
Desired Skills:
Prior international pharmaceutical company experience preferred. Managerial experience in a Drug Safety department desirable.

Medical degree (e.g., MD or DO) with the appropriate clinical and pharmacovigilance experience
Global Regulatory Affairs Lead, Medical Affairs Medical Director, Medical Affairs Study Management, Core Team Lead, BioMetrics, Clinical Pharmacology and Safety Operations.

Full-time Benefits - Full
Relocation Assistance Available - Yes
Bonus Eligible - Yes
Interview Travel Reimbursed - Yes

5+ to 7 years of experience
Minimum Education - Professional Degree
Willingness to Travel – Occasionally

Are you currently working as a Safety MD for a pharma or biotech company?
Are you experienced in Safety matters affiliated with biologics/large molecules specifically (vs. small molecules & devices
- Experience working in Safety as an MD specifically for Drug Development companies- Pharma / Biotech experience required - Please NO CRO Docs - they must have industry experience- they will report to a SR. MD- role will most likely be over a commercialized product (vs. early clinical dev Strong cross functional collaborator- Please NO Ops folks- Pharm Ds do NOT qualify - must have MD- Role is based in Brisbane, CA (with travel to our headquarters in San Rafael, CA)

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