The Global Clinical Safety Physician is the senior clinical safety expert and reports directly to the Global Patient Safety Head. The Global Patient Safety Manager is responsible for developing, managing, executing, and overseeing all aspects of the safety programmes for one (or more) pipeline asset(s) throughout the product(s') life cycle. GPSM plays a key role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnerships with the integrated development or product team to deliver on these safety commitments, while also demonstrating GPS expertise and leadership.Key Responsibilities
Provide GPS Medical leadership and ensure proactive pharmacovigilance for assigned product(s)Demonstrate advanced knowledge of safety concepts, per ICH, US, and international regulation/guidelines and GxPSynthesize complex data into actionable insights and translate technical issues into strategic discussionsBuild strong relationships with key stakeholders, representing and championing the role of safety in the organizationRepresent GPS Medical in inspections and audit activitiesFoster and support a collaborative working environment focused on inclusion, innovation, acceleration, and deliveryProvide training, coaching, and mentorExperience and knowledge sharing to further advance the goals of the GPS group and wider enterpriseMaintain compliance with corporate policies and relevant training curriculum
Education
Degree in Medicine; PhD (or other complementary degree) in scientific discipline is preferred
Experience
Minimum 5+ years' experience in the pharmaceutical industry or clinical care settingExperience in neuroscience or rare disease area is a plusKnowledge of drug development processDirect experience with global regulatory filing and interacting with major regulatory agencies e.g., FDA advisory Committees, Scientific Advice, etc.Expertise in pharmacovigilance with deep knowledge of regulatory requirements and guidelines pertaining to drug safetyThorough knowledge and understanding of safety, including clinical safety, deliverables, standards, and processes at a global level; including pre and post launch experienceProven record of successful clinical safety delivery with demonstrated examples of strategic influence to portfolio/clinical studies/programsDemonstrated success in implementing projects and/or innovating
Skills, Knowledge & Abilities
Strong analytical skills with the ability to critically interpret and apply scientific and clinical data for risk assessment and managementProficient understanding of epidemiology and statistics, with the ability to apply data‐driven decision‐makingFluent in English with highly effective written and verbal communication skillsExcellent interpersonal, organizational and negotiation skillsReceptive, engaging, and impactful contributorAbility to thrive in a matrixed environment, effectively collaborating across cross‐functional teams including Regulatory, Clinical Development, Medical Affairs, Commercial, and QualityStrong problem‐solving and critical thinking abilities, with a demonstrated ability to manage complex issues and competing prioritiesAbility to work on multiple projects and function effectively in a fast‐paced matrixed environmentCommitment to business ethics and compliance, ensuring alignment with corporate values, industry regulations, and best practices
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