Senior Director, Pharmacovigilance Intelligence
3 weeks ago
We are looking to add a new critical reporting directly to the Executive Director of Global Patient Safety (GPS) within our Quality and Compliance Centers of Excellence (CoE). As the GPS Pharmacovigilance Intelligence Leader, you'll become a central figure in ensuring patient safety by navigating the evolving landscape of international pharmacovigilance (PV) regulations.
You'll leverage your deep understanding of PV regulations to collaborate effectively with colleagues across GPS, Regulatory Affairs, Clinical Development, and Medical Affairs. Together, you'll spearhead the identification, review, interpretation, and implementation of new regulations impacting clinical safety and post-marketing pharmacovigilance activities for our clinical trials, marketed products, and potential territory expansions. This important role is key to ensuring all aspects of our GPS standards meet international requirement
JOB DUTIES:
Develop and implement the strategy for GPS to ensure excellence in PV Intelligence for pre- and post-marketing requirements impacting all countries where Regeneron performs clinical trials/studies, Early Access Programs, as well as commercialization of products, so that PV Intelligence becomes a key enabler of the overall GPS ambition to always meet international regulatory requirements.
Build an externally focused network with Health Authorities and industry associations to actively contribute and influence new PV regulations and best practices.
Lead PV Intelligence in all aspects from the strategy to day-to-day activities with operational excellence including ensuring fit-for-purpose processes and tools, as well as the development, retention, and attraction of key talents.
Collaborate with GPS, and other Regeneron functional areas to ensure effective oversight, maintenance, and improvement of the PV Intelligence, strategies, operations and expected outcome.
Act as the main GPS Liaison to Regeneron Regulatory Intelligence Committees (e.g., D-RISC, GR-3, RIACT) with a focus on pharmacovigilance-specific regulatory information.
JOB REQUIREMENTS:
15+ years of relevant PV experience.
Preferred degrees: PharmD
Excellent communication, interpersonal and negotiation skills with the ability to engage and influence others.
Ability to serve internally and externally as the company representative for pharmacovigilance intelligence subject matter expert.
Proactively maintaining up-to-date knowledge of guidelines, and regulations that govern pharmacovigilance activities for both clinical trial and post-marketing portfolio.
Proven ability to lead and work with others in a constructive, collaborative goal-oriented environment and has experience in developing teams.
Extensive experience in pharmacovigilance requirements and regulatory compliance within major pharmaceutical companies.
Strong quality and results-orientation coupled with a constant focus on areas for improvement and innovation to enhance business outcome.
Excellent stakeholder management including Health Authorities and other key external interfaces such as industry associations.
Maintains high ethical standards, including a commitment to the Company's values and behaviors.
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