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Manager Pharmacovigilance Planning

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Dec 3, 2022

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Job Details

Responsible for supporting Pharmacovigilance Operations 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 Pharmacovigilance Operations deliverables across compounds including process improvement initiatives. May have management of PV personnel responsibilities. 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 license partners). 

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

  • Serves as the liaison for internal and external personnel for PV deliverables in clinical programs, generally supports Phase III & IV programs with our without LP. 

  • Supports and/or leads other Pharmacovigilance Operations deliverables across compounds such as: preparation of line listings and SAE reconciliation listings in support of periodic aggregate reports or clinical studies. 

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

  • May be responsible for management of assigned PV personnel. 

  • Collaborates with Clinical Teams, CROs and License Partners to ensure proper management of pharmacovigilance deliverables in clinical programs. May lead a centralized functional activity. 

  • Contributes to and supports the completion of organizational projects and goals. Errors in judgment or failure to achieve results require a moderate expenditure of resources to rectify. 

This role might be for you if... 

  • Bachelor’s level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred. 

  • Significant safety and/or clinical experience in the pharmaceutical industry required; 8+ years (6 + years if Master’s Degree) of relevant Pharmacovigilance/Drug Safety experience required. 

  • Demonstrated successful management and completion of a Phase III/IV program(s) and leadership on projects of equivalent complexity. 

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.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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