(CW) Medical Director (TEMPORARY)

Role Summary

(CW) Medical Director, Pharmacovigilance: The Medical Director of Pharmacovigilance (PV) is responsible for strategic leadership and medical oversight of BioMarin 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 BioMarin products lifecycle.

Responsibilities

• Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data involving BioMarin products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting.
• Contribute to the preparation of departmental policies and SOPs that address the processing, analysis and reporting of safety information in accordance with evolving best practices.
• Assist in follow-up of important ICSRs to ensure relevant information is sought.
• Assist with literature review to identify adverse drug reactions as needed.
• 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 Report).
• Participate in the preparation and provision of PV training as needed.
• Serve as medical safety expert 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 medical advice and inform Global Head of PV and EU QPPV of critical issues, as appropriate.
• Oversee analysis of similar events for applicable interventional study safety reports.
• Participate in the preparation and revision of company core safety information and associated product labeling.
• Collaborate with Medical Directors in both Clinical Development and Medical (Commercial) 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, clinical study reports, NDA/BLA/CTD submissions and other documentation.
• Interface with business partners as needed in accordance with applicable safety Data Exchange Agreements.
• Provide support for internal and external PV audits as needed.
• Other duties as assigned.

Qualifications

• Minimum 5 years’ experience in PV with specific drug safety operational experience.
• Prior experience in pharmaceutical industry with international experience preferred.
• 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 Volume 9A for post-marketing PV and Volume 10 clinical trials directive; 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.
• Managerial experience in a Drug Safety department desirable.
• 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.

Education

• Medical degree (e.g., MD, DO) with the appropriate clinical and pharmacovigilance experience required.