Manager PV Planning
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, New York
- Start date
- Nov 28, 2022
View more
- Discipline
- Administration, Information Technology, General
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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 results across compounds including process improvement initiatives. May have management responsibilities. Frequently interacts with collaborators, vendors and/or functional peer group managers. May get along 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).
A typical day in this role might look like...
- Serves as the liaison for internal and external personnel for GPS results in clinical programs, generally supports Phase III & IV programs with our without Alliance Partner (AP)..
- Exercises independent judgment in running clinical program GPS results and maintaining compliance with SOPs, AP agreements and applicable worldwide regulations to ensure timely and consistent results.
- Supports and/or leads other PV Planning results across compounds such as: preparation of line listings and SAE reconciliation listings in support of periodic reports or clinical studies.
- Leads and/or chips in to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to PV Ops results whether internal or external to the department.
- Ensures development and maintenance of applicable SOPs and Working Instructions and training.
- May be responsible for management of assigned PV Planning personnel.
- Works on problems of diverse scope in which analysis of situation or data requires evaluation or identifiable factors.
- Figures out and pursues courses of action vital to acquire desired results.
- Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Collaborates with Clinical Teams, CROs and Alliance Partners to ensure proper management of pharmacovigilance results in clinical programs. May lead a centralized functional activity.
- Chips in 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.
- Bachelor’s level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred.
- Previous safety or clinical experience in the pharmaceutical industry required; 8+ years of Pharmacovigilance/Drug Safety experience required.
- Demonstrated successful management and completion of a Phase III/IV program(s) and leadership on projects of equivalent complexity.
Salary Range (annually)
$108,200.00 - $176,600.00Company
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
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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