Associate Director, Qppv Operations

4 maanden geleden

Amsterdam, Nederland Regeneron Pharmaceuticals Inc. Voltijd

We are seeking a seasoned Associate Director to head our Global patient Safety department. The Individual will be joining Regeneron’s industry leading scientific organization and will have a direct impact on PV System operations, administration of the QPPV Office and fulfilling pharmacovigilance responsibilities for hub markets. This is an opportunity to improve the global pharmacovigilance system including planning and operations.
As an Associate Director, QPPV Operations, Global a typical day might include the following:
Driving the day-to-day operations and directly improving the performance and efficiency of the QPPV Office.
Actively participating in process improvement initiatives e.g., the development and maintenance of relevant SOPs, WIs and supporting documents (global and local procedures).
Fostering and creating partner engagement to ensure cross functional partnership between global and local functions and the QPPV Office.
Leading team meetings and coordinating team activities such as, agenda development,, and maintenance of team’s delegation tracking.
Coordinating of the local QPPV PV network (vendor) and supporting continuous performance improvement within the local PV network.
Implementing and maintaining pharmacovigilance activities and associated quality management system at the national level including oversight of such activities in other Hub countries
**This role might be for you if**:
You have the ability to work on diverse and complex matters which may include analysis and communication of issues, data and PV processes.
You can build and strengthen partnerships internally and externally.
You are a diligent individual who works effectively with medical and commercial teams to align strategies and optimize processes,
You are knowledgeable about global pharmacovigilance requirements including PV quality systems and regulatory requirements.
You are a process driven individual who is both a skilled relationship builder and a meticulous worker.
To be considered for this opportunity, you must have a minimum of a Bachelor's degree and 7 years’ experience in pharmacovigilance with a background in departmental planning and operations. Previous experience in QPPV Office experience or served as local contact person for PV in the EU is preferred. We need someone adept at using drug safety databases or equivalent with strong expertise in Microsoft Office.
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.

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