Associate Manager Risk Management
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY
- Start date
- Apr 15, 2019
View more
- Discipline
- Clinical, Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Summary:
Assume significant role in RM activities including performing signal management activities; responding to regulatory agency queries; preparing periodic safety documents (PSURs, RMPs, etc). May assume role of RM Lead for assigned compounds
Job Duties:
Essential Functions required for the job. List both technical and managerial requirements if applicable.
With support from Risk Management Lead or Head of RM:
1. Monitor the safety profile of assigned compounds to identify safety signals, and develop and execute a plan for their evaluation.
2. Author regulatory documents for assigned compounds
3. Prepare and deliver presentations at SMT meetings; participate in Dose Escalation meetings
4. Participate in other risk management activities as appropriate for assigned compounds.
5. May represent Risk Management for assigned compounds on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron
In addition:
6. Actively participate in the development and maintenance of relevant SOPs and supporting documents.
7. Actively participate in process improvement activities within PVRM.
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 utilize PVRM safety system database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) safety findings.
Previous safety or relevant clinical experience in the pharmaceutical industy required, typically with at least 5 years of risk
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
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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