Executive Director, Medicinal Product Safety
vor 3 Wochen
Job Summary
We are seeking an experienced Executive Director to lead our Drug Safety and Risk Management team at Organon. This is a critical role that requires a strong scientific background, excellent leadership skills, and the ability to drive strategic decision-making.
Key Responsibilities
- Strategic Leadership
- Develop and implement the overall safety strategy and procedures for assigned therapeutic area product portfolios.
- Lead cross-functional teams to ensure alignment with safety strategy and company objectives.
- Scientific Expertise
- Provide scientific safety assessment of assigned products, driving comprehensive and customer-focused strategic patient safety expertise.
- Ensure effective benefit-risk decision-making through guidance, expertise sharing, coaching, and training.
- Regulatory Compliance
- Ensure compliance with ICH/FDA/EMA guidelines and regulations governing pharmacovigilance and clinical trials.
- Liaise with regulatory agencies and internal stakeholders to ensure timely and high-quality data management and reporting.
- Team Leadership
- Lead and manage a team of safety physicians and scientists, providing oversight and guidance on safety-related activities.
- Develop and implement training programs to ensure staff are equipped to handle safety-related tasks and responsibilities.
Requirements
- Medical degree with clinical experience in a relevant field (e.g., women's health, internal medicine, cardiology, neuroscience).
- 10+ years of experience in the pharmaceutical industry, with 5-10+ years in drug safety and pharmacovigilance.
- Extensive knowledge of PV deliverables, standards, and processes at a global level.
- Experience with benefit-risk profile process implementation, data analysis, signal management, and benefit-risk monitoring and evaluation.
- Excellent leadership, communication, and analytical skills, with the ability to build and maintain strong relationships with stakeholders.
About Organon
Organon is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have a diverse and trusted portfolio of health solutions, and our vision is to create a better and healthier every day for every woman.
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