Senior Director, Benefit/Risk Medical Adviser to the QPPV (Pharmacovigilance)

Location: Munich, Germany (Hybrid)

Salary: 157,500–262,500 annually

Company

hirify.global develops medicines for people with serious diseases through science and innovation.

What you will do

• Advise the EU/UK 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 product lifecycle.
• Provide expert input to regulatory submissions, aggregate safety reports, safety communications and responses to health authority requests.
• Apply qualitative and quantitative benefit-risk methods using clinical, epidemiological, real-world and patient-preference evidence.
• Advise on PASS protocols and the interpretation of epidemiological, pharmacoepidemiological and real-world data.
• Strengthen pharmacovigilance processes, QPPV oversight, governance and inspection readiness while partnering with safety, regulatory, clinical, quality, legal, commercial and supply functions.

Requirements

• 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, plus working knowledge of US FDA safety reporting requirements.
• Expertise in signal evaluation, qualitative and quantitative benefit-risk assessment, risk management planning and safety aspects of regulatory submissions.
• Strong knowledge of relevant ICH guidelines and real-world, epidemiological and pharmacoepidemiological evidence.
• Authoritative medical judgement and the ability to communicate scientific advice credibly with senior and cross-functional stakeholders.

Nice to have

• Experience supporting or deputising for a QPPV, working within a QPPV Office, or supporting inspections and audits.
• Pharmaceutical Medicine qualification, specialist registration or experience across additional regulatory jurisdictions.
• Experience applying patient-preference evidence or quantitative benefit-risk methods.
• An additional EU language relevant to the location.

Culture & Benefits

• Inclusive workplace culture and equal opportunity employment.
• Competitive total rewards package, which may include annual bonuses, incentive plans and equity awards.
• Benefits may include pension or retirement plans, health and wellness programs, insurance, paid time off and family support.
• Many roles are performed onsite or with defined onsite expectations; this position is identified as hybrid.