Global Patient Safety & Pharmacovigilance Physician – Cardio‑Renal‑Metabolism
ageneo Life Science Experts (Interim Solutions) GmbH · Bade-Wurtemberg
Stellenbeschreibung
About the role
This senior position leads global patient safety, pharmacovigilance and risk‑management initiatives for cardio‑renal‑metabolism compounds across late‑stage development and post‑marketing. The role works closely with clinical development, medical affairs and global patient engagement teams to ensure a patient‑centric benefit‑risk profile.
Key responsibilities
- Design and implement proactive, patient‑focused risk‑management strategies for assigned compounds.
- Oversee all pharmacovigilance activities, including database setup, ongoing safety monitoring and issue resolution.
- Collaborate with Clinical Development, Global Patient Engagement, Epidemiology and Medical Affairs to produce benefit‑risk assessments and safety‑focused post‑authorization studies.
- Analyze clinical trial safety data for inclusion in trial reports and regulatory submissions.
- Provide medical‑scientific input for regulatory documents such as PSURs, DSURs, RMPs and Clinical Overview Statements.
- Chair multidisciplinary Benefit‑Risk Teams and keep senior management informed of safety profiles and recommended actions.
Required profile
- Medical degree with clinical and/or clinical‑research experience in cardio‑renal‑metabolism.
- Strong knowledge of patient‑safety strategies and pharmacovigilance regulations in major markets.
- Experience in clinical development and regulatory submissions is advantageous.
- Excellent scientific understanding of the therapeutic area and the pharmaceutical industry.
- Strong interpersonal, communication and ethical standards.
- Fluent written and spoken English.
Required skills
What we offer
- Strategic, development‑focused role with high impact on new drug submissions.
- Global, intercultural work environment.
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ageneo Life Science Experts (Interim Solutions) GmbH
Bade-Wurtemberg
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