Global Patient Safety Manager
Angelini Pharma · Rome
Job description
About the role
We are looking for an experienced physician to lead global patient safety for one or more pharmaceutical assets. Reporting to the Global Head of Patient Safety, you will shape safety strategies across the entire product lifecycle, from early development to post‑marketing.
Key responsibilities
- Act as the Global Safety Physician lead, providing strategic medical oversight throughout the product lifecycle.
- Demonstrate advanced knowledge of safety concepts per ICH, US, and international regulations and GxP.
- Synthesize complex safety data into actionable insights for senior governance bodies.
- Build and maintain strong relationships with Clinical Development, Regulatory Affairs, Medical Affairs, and other stakeholders.
- Represent Global Patient Safety in inspections, audits, and regulatory interactions.
- Foster an inclusive, innovative, and collaborative working environment.
- Provide training, coaching, and mentorship to the safety team.
- Share experience and knowledge to advance the goals of the Global Patient Safety group.
- Ensure compliance with corporate policies and relevant training curricula.
Required profile
- Medical Doctor (MD) with a strong scientific mindset; PhD or advanced scientific qualification is a plus.
- Minimum 5 years of pharmaceutical industry experience in Clinical Safety, Pharmacovigilance, Drug Safety, or Clinical Development in a physician‑led role.
- Experience interacting with global regulatory authorities (FDA, EMA, MHRA, PMDA, etc.).
- Deep knowledge of pharmacovigilance regulations, drug development processes, and safety deliverables.
- Experience supporting regulatory filings, advisory committees, inspections, and due‑diligence activities.
- Experience in neuroscience or rare‑disease therapeutic areas is advantageous.
Required skills
- Pharmacovigilance
- Regulatory affairs
- Clinical safety
- ICH guidelines
- GxP compliance
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Published 1 mese fa
Expires tra 1 settimana
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Angelini Pharma
Rome