Temp Manager, PV Planning

Pay Range: $50 - $70/hr

Remote Role (US Only)

12 Month Contract

Regeneron is seeking a Temporary Manager of Pharmacovigilance (PV) Planning

In this role, a typical day might include:

Responsible for supporting PV Planning in the successful conduct of safety-related activities supporting all stages (including late stage) clinical compounds in accordance with applicable GCPs and/or regulations. Supports PV Planning deliverables across compounds including process improvement initiatives. Frequently interacts with collaborators, vendors and/or functional peer group managers. May interact with senior management on matters concerning specific compounds or issues within scope of responsibilities. Interactions normally involve matters between functional areas or collaborations (support of clinical programs; interactions with supporting CROs and Alliance Partners (AP)).

This role might be for you if you can:

Serve as the liaison for internal and external personnel for GPS deliverables in clinical programs, generally supports Phase I, II, III & IV programs with/without AP.

Exercise independent judgment in managing clinical program GPS deliverables and maintaining compliance with SOPs, AP agreements and applicable worldwide regulations to ensure timely and consistent deliverables.

Support PV Planning deliverables across compounds such as preparation of line listings and SAE reconciliation listings in support of periodic reports or clinical studies.

Work on problems of diverse scope in which analysis of situation or data require evaluation or identifiable factors. 

Determine and pursues courses of action necessary to obtain desired results.  

Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Collaborate with Clinical Teams, CROs and AP to ensure proper management of pharmacovigilance deliverables in clinical programs.

Support the completion of organizational projects and goals.

To be considered for this opportunity, you must have the following:

Bachelor’s degree in life sciences required (Biology, Pharmacy, Nursing or equivalent). An advanced degree is preferred

Five (5) or more years of Pharmacovigilance/Drug Safety experience required. 

Demonstrated successful management and completion of a Phase I, II, III & IV program(s) and leadership on projects of equivalent complexity.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation