Director of Risk Management
3 weeks ago
Regeneron Ireland DAC is seeking a highly skilled and experienced Director, Risk Management to join our team. As a key member of our Global Patient Safety (GPS) department, you will be responsible for assisting in drug safety risk management planning and driving planning, operations, and processes globally to ensure the successful delivery of risk management pharmacovigilance (PV) requirements of Regeneron's worldwide portfolio.
Key Responsibilities:- Support the development, execution, and maintenance of Risk Management strategies (e.g., US REMS, EU risk minimization measures) as determined by GPS stakeholders.
- Provide planning in support of the global portfolio, including establishing and maintaining Risk Management planning and processes to ensure compliance with global regulations related to assessments.
- Serve as the liaison between GPS/Regulatory/REMS Operations/Qualified Person for PV Office (QPPVO)/External vendors and cross-functional partners, acting as a Global Risk Management ambassador raising awareness of customer/stakeholder needs and dependencies.
- Lead REMS activities and serve as a point of contact for REMS external vendor.
- Provide tracking and key performance metrics for GPS.
- 8+ years' experience in US or EU risk management operations, including risk management planning and leadership experience in the pharmaceutical industry.
- 5+ years of leading a matrix role that encompasses working across all areas of an organization and people management experience.
- Preferred minimum of 5 years of international pharmaceutical activities.
- Strong leadership capabilities and presence, influencing skills, interpersonal, verbal, and written communication skills, organizational and workload planning skills, along with the ability to manage multiple different projects simultaneously.
- Expertise leading large-scale, strategic initiatives related to drug development, risk management/PV operations, and global regulatory requirements.
- Preferred advanced life sciences degree: MPH, PharmD is an advantage.
Regeneron Ireland DAC offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.
We will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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Director of Risk Management
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Director, Risk ManagementRegeneron Ireland DAC is seeking a highly skilled and experienced Director, Risk Management to join our team. As a key member of our Global Patient Safety (GPS) department, you will be responsible for assisting in drug safety risk management planning and driving planning, operations, and processes globally to ensure the...
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Director of Risk Management
3 weeks ago
United Kingdom Regeneron Ireland DAC Full time £12,000Job Title: Director, Risk ManagementRegeneron Ireland DAC is seeking a highly skilled and experienced Director, Risk Management to join our team. As a key member of our Global Patient Safety (GPS) department, you will be responsible for assisting in drug safety risk management planning and driving planning, operations, and processes globally to ensure the...
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