Global Safety Strategy Director
Vor 3 Tagen
Overview
Organon is seeking an experienced Executive Director of Safety Science to lead our global safety strategy and operations. This role will be responsible for setting and implementing the overall safety strategy and procedures for our assigned therapeutic area product portfolio.
Key Responsibilities
- Strategic Leadership
- Develop and implement the global safety strategy and procedures for our assigned therapeutic area product portfolio.
- Lead the development of comprehensive and customer-focused strategic patient safety expertise.
- Safety Operations
- Ensure the scientific safety assessment of assigned products is driven by comprehensive and customer-focused strategic patient safety expertise.
- Manage the review of worldwide reports on adverse events, including confirming causality assessments.
- Regulatory Compliance
- Ensure compliance with ICH/FDA/EMA guidelines and regulations governing pharmacovigilance.
- Liaise with regulatory departments to evaluate benefit-risk and safety profiles of products.
- Team Leadership
- Lead and manage a team of safety physicians and scientists.
- Develop and implement training programs for pharmacovigilance staff.
Requirements
- Medical degree with clinical experience in a relevant field.
- 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.
Preferred Qualifications
- Board certification in a relevant field.
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 are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants.
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