The Director of GPS (Global Patient Safety) Risk Management Lead will report directly to the Sr. Director, GPS Risk Management is a key position responsible for assisting in drug safety risk management planning and will drive planning, operations, and processes globally to ensure the successful delivery of risk management pharmacovigilance (PV) requirements of Regeneron’s worldwide portfolio.
This global role will represent and manage internal and external relationships related to risk management implementation and will work cross-functionally, serving as a key planning lead, working in coordination with all areas of GPS, along with Regeneron stakeholders and pharmacovigilance (PV) vendors.
The role will be accountable for assisting in all elements of planning, overseeing status reporting, managing risks and issues, collaborating with stakeholders, developing operational methodologies, and proactively communicating with stakeholders on the delivery of Risk Management in support of the portfolio.
In this role, a typical day might include:
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You will be responsible for providing operations for Risk Management planning and pivotal risk management implementation and operations activities globally across the entire product lifecycle for Regeneron medicines and compounds.
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Key responsibilities include supporting the development, execution, and maintenance against the Risk Management strategies (e.g., US REMS, EU risk minimization measures) as determined by GPS stakeholders and provide planning in support of the global portfolio.
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Establish and maintain Risk Management planning and processes to ensure compliance with global regulations related to assessments working in close collaboration across GPS areas, Regeneron stakeholders and vendors.
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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.
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Responsible for leading REMS activities and serve as a point of contact for REMS external vendor.
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Responsible to provide tracking and key performance metrics for GPS.
This role might be for you if can:
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Ensure the risk assessment processes are continuously improved to reflect best practices, regulatory trends, and guidelines working across with GPS, and Regeneron stakeholders.
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Serve as the in-house Risk Management operations expert and provide subject matter expertise on the implementation and delivery of risk management programs globally as required.
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Work closely with QPPVO to understand risk management operational needs and support.
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Support and/or participate in Regulatory Agency interactions including audits/inspections.
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Maintain expertise in the regulatory environment, regulations, and requirements for Global Risk Management and REMS activities.
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Other duties as assigned.
This role might be for you if:
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8+ years' experience in US or EU risk management operations, including risk management planning and leadership experience in the pharmaceutical industry required.
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5+ years of leading a matrix role that encompasses working across all areas of an organization and people management experience.
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Preferred minimum of 5 years of international pharmaceutical activities
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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.
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Expertise leading large-scale, strategic initiatives related to drug development, risk management/ PV operations and global regulatory requirements.
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Preferred advanced life sciences degree: MPH, PharmD is an advantage.
#GDPSJobs
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is 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. The Company 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.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$198,000.00 - $330,000.00
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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