Associate Manager, Global Patient Safety
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, New York
- Start date
- Nov 23, 2022
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- Discipline
- Administration, Clinical, Manufacturing & Production
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
The Associate Manager of Global Patient Safety (GPS) plays a scientific role in supporting the safety strategies for compounds in clinical development and post-marketing phases. This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.
With occasional support/mentorship from GPS Lead, a typical day in this role might be like....
- Perform signal detection activities for assigned products in line with approved safety surveillance plan
- Perform signal evaluation for any identified signals and author the safety evaluation reports
- Handle preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
- Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds and products
This role might be for you if...
- Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
- Provide a background that includes: Master degree, PharmD, PhD
- Offers 3-5 years of safety surveillance activities
- Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 3-5 years of risk management or relevant pharmaceutical/ biotech industry or health authority
- Clinical experience and/or Industry experience in the TA of interest is a plus
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
- 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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