Job Title: Global Patient Safety Manager
Roma, IT
This is a highly visible position offering the opportunity to partner with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, and senior governance bodies to ensure patient safety remains at the center of critical business and development decisions.
The ideal candidate is a physician with strong clinical and drug safety expertise who thrives in a highly collaborative, science-driven environment and is passionate about translating complex safety data into meaningful actions that improve patient outcomes.
Key Responsibilities
You will act as the Global Safety Physician lead for assigned product(s), providing strategic medical oversight throughout the product lifecycle, ensuring proactivee pharmacovigilance. You will:
- Demonstrate advanced knowledge of safety concepts, per ICH, US, and international regulation/guidelines and GxP.
- Synthesize complex data into actionable insights and translate technical issues into strategic discussions.
- Build strong relationships with key stakeholders, representing and championing the role of safety in the organization.
- Represent Global Pateinet Safety Medical in inspections and audit activities.
- Foster and support a collaborative working environment focused on inclusion, innovation, acceleration, and delivery.
- Provide training, coaching, and mentor.
- Experience and knowledge sharing to further advance the goals of the GPS group and wider enterprise.
- Maintain compliance with corporate policies and relevant training curriculum.
Requirements
- On top of what we would expect:
Minimum 5 years of pharmaceutical industry experience, with demonstrated expertise in Clinical Safety, Pharmacovigilance, Drug Safety, or Clinical Development, gained in a physician-led role. - Experience in neuroscience or rare disease area is a plus.
Knowledge of drug development process - Direct experience interacting with global regulatory authorities, including FDA, EMA, MHRA, PMDA, or other major agencies.Expertise in pharmacovigilance with deep knowledge of regulatory requirements and guidelines pertaining to drug safety.
-
Experience supporting regulatory filings, advisory committees, inspections, and due diligence activities.
-
Thorough knowledge and understanding of safety, including clinical safety, deliverables, standards, and processes at a global level; including pre and post launch experience.
- Proven record of successful clinical safety delivery with demonstrated examples of strategic influence to portfolio/clinical studies/programs.
- Demonstrated success in implementing projects and/or innovating.
The salary for this role starts from 53.600€ gross per year, depending on experience and location. The offer is determined based on gender-neutral criteria, including relevant skills, competencies, and experience.
Angelini Pharma is an equal Opportunity Employee
We believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment.