Senior Global Clinical Safety Leader
Angelini Pharma ·
The Global Clinical Safety Physician is a 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 Include
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 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 GPS 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. 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 setting. Experience in neuroscience or rare disease area is a plus. Knowledge of drug development process Direct 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 safety. 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. Skills, Knowledge