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Director Global PV Operations

Job Description

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Provides direction and guidance to the PV Case Management function to ensure streamlined and efficient process, and fulfillment of support needed from other PV functions as well as other Regeneron functions.

A typical day in this role might look like....

· Maintains oversight of PV Case Management’s deliverables, including but not limited to compliance and quality standards.

Case Management vendors and study CROs to Regeneron management

· Maintains oversight of PV Case Management’s collaboration with other PV functions within and outside of PV to ensure provision of timely and high-quality PV data.

· Maintains oversight of collaboration with License Partners on relevant PV deliverables to ensure compliance with Safety Data Exchange Agreements.

· Exercises independent judgment in managing deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.

· Effectively manages workload to ensure overall compliance with PV standards

· Takes initiative in the ongoing process improvement for quality and compliance

· Authors new and updates to SOPs and Working Instructions, and conduct related training.

· Leads continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all PV Case Processing deliverables, whether internal or external to the department.

· Well informed on relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

· Extensive experience with managing direct reports on complex projects.

This job might be for you if...

Minimal educational requirements: Equivalent experience (include # of years) in lieu of degree Associates Degree, Bachelors Degree, Masters Degree, Ph.D., PharmD, MD, Board Certified MD

· Pharmacy, nursing or degree in healthcare and/or life sciences required, advanced degree preferred.

· Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry required;

typically with 12 + years of Pharmacovigilance/Drug Safety experience.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.