As part of our global expansion strategy our Global Patient Safety (GPS) organization is looking for a qualified drug safety leader to serve as the delegate for the EU QPPV (Qualified Person Responsible for Pharmacovigilance) for the European (EU) region.
The incumbent will report directly to the EU QPPV of GPS and will collaborate with the leadership GPS team, as well as a number of key functional areas in Regeneron, including: Industrial Operations and Product Supply – IOPS, regulatory affairs, clinical development, medical affairs.
They will be a significant partner to our EU QPPV and help ensure all aspects of EU PV activities and requirements are effectively led and supported.
We are building a solid QPPV office who will help coordinate and improve our PV System and further improve EU PV operations within our organisation.
- The Deputy of EU-UK QPPV will serve as the delegate for the EU-UK QPPV, and as required, will serve as a company representative for pharmacovigilance (PV) of the European (EU) region for Regeneron’s Global Patient Safety (GPS) organization and support the delivery of PV activities, improvements, which includes relevant European legislation and as detailed in GVP Module 1 - Pharmacovigilance systems and their quality systems (Section I.C.1.3).
- The Deputy of EU-UK QPPV will support the EU-UK QPPV for EU Health Authorities and the EMA, and the UK MHRA on a 24-hour basis and support pharmacovigilance inspections.
- This role will work in close partnership with the EU-UK QPPV and GPS, and other Regeneron functional areas (Industrial Operations and Product Supply – IOPS, regulatory affairs, clinical development, medical affairs, etc.) to ensure effective oversight, maintenance, and improvement of the PV system.
- They will partner to ensure all aspects of proper functioning of local country/region pharmacovigilance activities including pharmacovigilance inspections.
- The Deputy of EU-UK QPPV will support ensuring pharmacovigilance/safety related requests from regulatory authorities are answered fully and promptly to address safety and emerging concerns.
- They will have oversight of the PSMF (Pharmacovigilance System Master File) and be in position of authority to ensure and to verify that the information contained in PSMF is an accurate and up-to-date reflection of the PV system and can ensure readiness for a Health Authority inspection or a request.
- Actively participates in continuous improvement activities across the GPS organization, including cultivating cross-functional relationships and the opportunity to assist the EU-UK QPPV to develop a team supporting PV activities in Europe and other regions where required.
- Strong abilities to lead, and effectively communicate, including proficient writing skills.
- Ability to serve as acting delegate, as required to liaise as the company representative for pharmacovigilance as a safety expert in the EU for Regeneron’s compounds and approved medicines.
- Understands and maintains up-to-date knowledge of EU and ICH guidelines, and regulations that govern pharmacovigilance activities for both clinical trial and post-marketing portfolio.
- Proven track record of leadership and collaboration with others, in a constructive and goal-oriented environment.
- An ability to work across organizational levels, effectively communicating safety viewpoints and findings as required.
- Maintains high ethical standards, including a commitment to the Company's values and behaviors.
- Preferred degrees: University degree of Pharmacy / Nursing or related scientific degree; PhD / MD degree preferred.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.