04 ago
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Angelini Pharma
|
Roma
04 ago
Angelini Pharma
Roma
ppAre you a physician with experience in Clinical Safety, Pharmacovigilance, or Drug Development looking to shape the safety profile of innovative therapies on a global scale? We are seeking an experienced bGlobal Patient Safety Manager /b to serve as the clinical safety lead for one or more development and/or marketed assets. Reporting directly to the Global Head of Patient Safety, you will play a pivotal role in defining and driving the global safety strategy across the product lifecycle, from early development through post-marketing. /p pThis 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. /p pThe 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. /p h3Key Responsibilities /h3 pYou 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: /p ul liDemonstrate advanced knowledge of safety concepts, per ICH, US, and international regulation/guidelines and GxP. /li liSynthesize complex data into actionable insights and translate technical issues into strategic discussions. /li liBuild strong relationships with key stakeholders, representing and championing the role of safety in the organization.
/li liRepresent Global Pateinet Safety Medical in inspections and audit activities. /li liFoster and support a collaborative working environment focused on inclusion, innovation, acceleration, and delivery. /li liProvide training, coaching, and mentor. /li liExperience and knowledge sharing to further advance the goals of the GPS group and wider enterprise. /li liMaintain compliance with corporate policies and relevant training curriculum. /li /ul h3Requirements /h3 pYou are a Medical Doctor (MD) with a strong scientific mindset, ideally supported by a PhD or other advanced qualification in a relevant scientific field. /p pOn top of what we would expect: /p ul liMinimum 5 years of pharmaceutical industry experience, with demonstrated expertise in Clinical Safety, Pharmacovigilance, Drug Safety, or Clinical Development, gained in a physician-led role. /li liExperience in neuroscience or rare disease area is a plus. /li liKnowledge of drug development process /li liDirect 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. /li liExperience supporting regulatory filings, advisory committees, inspections,
and due diligence activities. /liliThorough knowledge and understanding of safety, including clinical safety, deliverables, standards, and processes at a global level; including pre and post launch experience. /li liProven record of successful clinical safety delivery with demonstrated examples of strategic influence to portfolio/clinical studies/programs. /li liDemonstrated success in implementing projects and/or innovating. /li /ul h3What you'll bring /h3 pYou combine strong scientific and clinical judgment with the ability to translate complex safety data into clear, actionable insights. Comfortable working in a fast-paced global matrix environment, you collaborate effectively across Regulatory, Clinical Development, Medical Affairs, Commercial, and Quality teams. You are a confident communicator and relationship builder, with excellent problem-solving, influencing, and prioritization skills. With a data-driven mindset, solid knowledge of epidemiology and statistics, and a strong commitment to ethics, compliance, and patient safety, you thrive in leading complex discussions and driving informed decision making. /p pThe 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. /p h3Angelini Pharma is an equal Opportunity Employee /h3 pWe believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment. /p /p #J-18808-Ljbffr
📌 Global Patient Safety Manager (Roma)
🏢 Angelini Pharma
📍 Roma