Senior Director, Benefit / Risk Medical Adviser to the QPPV

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director, Benefit/Risk Medical Adviser EU/UK to join our QPPV Office. Reporting directly to the EU/UK QPPV, you will provide authoritative medical, safety and benefit-risk advice supporting oversight of authorised products throughout their lifecycle. You will combine clinical judgement with qualitative and quantitative approaches, including patient preferences, real-world data and epidemiological evidence, while partnering with colleagues across Global Patient Safety, Regulatory Affairs, Clinical Development and other functions.,

• Advise the QPPV on signal validation, evaluation and prioritisation, benefit-risk assessments, Risk Management Plans and health hazard assessments.
• Shape medical and safety strategy across clinical development and the post-authorisation lifecycle, including emerging clinical trial data and evolving safety evidence.
• Provide expert input to regulatory submissions, aggregate safety reports, safety communications and responses to health authority questions, requests and referrals.
• Apply qualitative and quantitative benefit-risk approaches using clinical, epidemiological, real-world and patient-preference evidence, where appropriate.
• Advise on PASS protocols and the appropriate use and interpretation of epidemiology, pharmacoepidemiology and real-world data.
• Develop and optimise CCSI, RMP, aggregate reporting and pharmacovigilance processes, identifying gaps and strengthening QPPV oversight.
• Partner across safety, regulatory, clinical, quality, legal, commercial, local pharmacovigilance and product supply functions while contributing to governance and inspection readiness.
• Provide credible medical challenge, translate complex safety science into clear advice and influence senior stakeholders without direct authority.
  
  A medical qualification, such as MBChB, MBBS or MD, with a current or historic medical licence.
• Extensive post-qualification experience in drug safety or pharmacovigilance within the pharmaceutical or biotechnology industry, or a health authority.
• Deep knowledge of EU GVP and the EU/UK pharmacovigilance legislative framework, with working knowledge of US FDA safety reporting requirements.
• Proven expertise in signal evaluation, qualitative and quantitative benefit-risk assessment, risk management planning and the safety aspects of regulatory submissions.
• Strong knowledge of relevant ICH guidelines and the application of real-world, epidemiological and pharmacoepidemiological evidence.
• Authoritative medical judgement, clear scientific communication and the ability to operate credibly with senior and cross-functional stakeholders.
• Experience supporting or deputising for a QPPV, working within a QPPV Office, or supporting inspections and audits is preferred.
• A Pharmaceutical Medicine qualification, specialist registration or experience across additional regulatory jurisdictions is preferred.
• Experience applying patient-preference evidence or quantitative benefit-risk methods, or an additional EU language relevant to the location, is preferred.
  
  Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the
recruitment process. If you have any questions, please speak with your recruiter.