Global Director of Pharmacovigilance
vor 3 Wochen
About the Role
At Organon, we are seeking a highly skilled Executive Director to lead our Safety Science team. As a member of our Global Pharmacovigilance and Safety Science (GPSS) Department, you will be responsible for setting and implementing our overall safety strategy and procedures for assigned therapeutic area product portfolios.
Main Responsibilities
- Develop and implement comprehensive safety strategies and procedures for assigned product portfolios, ensuring alignment with company objectives and regulatory requirements.
- Lead interactions with Organon governance committees and regulatory agencies regarding product safety issues, providing expert scientific advice and guidance.
- Build strong relationships with cross-functional teams to influence and ensure alignment of development, regulatory, and medical strategies with safety strategies.
- Ensure the scientific safety assessment of assigned products is driven by comprehensive and customer-focused strategic patient safety expertise.
- Oversee assigned core safety science processes and liaison between GPSS teams for PV system implementation and maintenance.
- Develop and lead a team of safety physicians and scientists, providing oversight and guidance on product safety issues.
Requirements
- Medical degree, ideally with clinical experience in a relevant field, and experience in International Drug Safety.
- At least 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.
- Comprehensive knowledge of pharmacovigilance and clinical trial legislations and regulations.
About Organon
Organon is a global healthcare company focused on delivering innovative health solutions that enable people to live their best lives. We have a diverse portfolio of products and are committed to making a world of difference for women, their families, and the communities they care for.
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