Executive Director, Drug Safety
vor 4 Wochen
Job Summary
Organon is seeking a highly experienced and skilled Executive Director, Drug Safety to lead our global safety strategy and ensure the safe use of our medicinal products and medical devices. As a key member of our Pharmacovigilance and Safety Science (GPSS) Department, you will be responsible for setting and implementing the overall safety strategy and procedures for our assigned therapeutic area product portfolio.
Key Responsibilities
- Develop and implement a comprehensive safety strategy and procedures for our assigned therapeutic area product portfolio.
- Lead all interactions regarding product safety issues with Organon governance committees and regulatory agencies.
- Build strong relationships with cross-functional teams to ensure alignment of development, regulatory, and medical strategies with safety strategy and company objectives.
- Ensure the scientific safety assessment of assigned products is driven by comprehensive and customer-focused strategic patient safety expertise.
- Oversee the development and maintenance of core safety science processes and liaison between different GPSS teams for PV system implementation and maintenance.
- Line-manage and develop staff in the Safety Science Therapeutic Areas at the GPSS Department.
Requirements
- Medical degree, ideally with clinical experience as a specialist in women's health, internal medicine, cardiology, neuroscience, or equivalent.
- At least 10 years of experience in the pharmaceutical industry, with 5-10 years in drug safety and pharmacovigilance in a global environment.
- Extensive knowledge and understanding of PV deliverables, standards, and processes at a global level.
- Knowledge and experience in pharmacoepidemiology, benefit-risk profile process implementation, data analysis, signal management, and benefit-risk monitoring and evaluation.
- Comprehensive knowledge of pharmacovigilance and clinical trial (ICH/GVP/GCP) legislations and relevant regulations governing pharmacovigilance globally.
- Excellent verbal and written communication skills, analytical skills, and demonstrated leadership skills.
- Able to build and maintain good relationships with a strong customer focus and represent the company on benefit-risk related matters in front of health authorities or other important external organizations or events.
Preferred Qualifications
- Board certification.
About Organon
Organon is a $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions.
Equal Employment Opportunity
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
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