Senior Manager, Global Patient Safety Sciences
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Basking Ridge, New Jersey
- Start date
- Jun 1, 2023
View more
- Discipline
- Administration, Clinical, Manufacturing & Production
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
SUMMARY:
The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.
JOB DUTIES:
A typical day might include the following:- Complete signal detection activities in line with approved safety surveillance plan
- Perform signal evaluation for any identified signals and author the safety evaluation reports
- Manage 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
- Participate in other risk management activities as appropriate for assigned compounds
- We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
- Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents
JOB REQUIREMENTS:
- Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
- Ability to work with a safety system database for purposes of medical case review and simple querie
- Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
- Ability to effectively communicate (verbal and written) safety findings
- Provide a background that includes: Master's, PhD, or PharmD
- Offers 7+ years of relevant risk management experience in the pharmaceutical/ biotech industry or health authority
Salary Range (annually)
$141,800.00 - $231,400.00Company
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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