Shire Jobs

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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.