Senior Director, Pharmacovigilance Physician

The Senior Director, Pharmacovigilance (PV) Physician will provide broad support of activities requiring medical safety input for assigned products, pre- and post-approval. They will support and/or lead periodic safety signaling reviews and meetings, as well as perform individual and aggregate case review. The Senior Director will also participate, in varying degrees, on clinical teams/programs and other intra and/or inter-departmental activities and initiatives.

Ensure PV Medical Safety activities are performed in compliance with all applicable regulations and SKLSI standards.
• Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
• Provide oversight for the safety aspects for clinical studies, including participation at DMC meetings, and development and maintenance of the company core safety information.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, informed consent forms, final study reports, IB/RSI and other documents as needed.
• Provide timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources as needed.
• Lead the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices
• Assess safety signals and trends and proactively manage any potential safety issues.
• Determine need for pharmacoepidemoiology input and liaise with external pharmacoepidemiologist.
• Lead development of Risk Management Plans, implementation and evaluation of their effectiveness.
• Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
• Author analysis of similar events (AOSE) and individual case comments for ICSRs.
• Accountable for medical evaluation/interpretation of aggregate safety data of assigned product(s) including signal detection and evaluation, regulatory safety reports (DSUR, PADER, PBRER/PSUR) and ad hoc safety assessments.
• Maintain knowledge of global regulatory authority regulations including FDA and EMA.
• Formulate response strategies for safety-related health authority and ethics committee requests.
• Represent PV in communications with health authorities such as the FDA.
• Participate in departmental development activities including SOP and Work Instructions development.
• Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective
• Contribute to the training, leadership and continuing education for department staff.
• Provide a contributory role in Partner /Affiliate agreements and interactions, as needed
• Other duties as assigned.

• MD degree or equivalent with clinical post-training resulting in eligibility for a US medical board certification.
• MPH or pharmacoepidemiology expertise a plus.
• A minimum of 12 years of relevant drug safety experience in the biotechnology/pharmaceutical industry, including a minimum of 8 years of safety leadership experience.
• Neurology, psychiatry, or CNS-related disease experience also a plus.
• Thorough understanding of U.S. pharmacovigilance regulations, GCP and International Conference on Harmonisation (ICH) guidelines.
• Working knowledge of validated drug safety databases (preferably ARGUS) and MedDRA.
• Extensive knowledge of all types of aggregate safety reports.
• In-depth understanding of the drug development process.
• Extensive experience in partnering with vendors to achieve results.
• Exceptional written and verbal communication skills.
• Ability to build and sustain trusted relationships both internally and externally.
• Proficient computer skills, including Microsoft Word, PowerPoint and Excel.