This job has expired

You will need to login before you can apply for a job.

Dir Global Patient Safety

Employer
Regeneron Pharmaceuticals, Inc.
Location
Basking Ridge, New Jersey
Start date
Aug 6, 2022

View more

You need to sign in or create an account to save a job.

Job Details

Reporting to the Global Patient Safety (GPS) TA Lead, the Director, GPS provides PV and RM expertise, leadership, and mentorship of team members within the TA matrix. You may also have direct management of relevant GPS personnel. Responsible for contributing to the management of, and have shared accountability for the safety profile with the TA. This includes results that support products within the assigned portfolio. This position requires ability to work with and influence colleagues in a matrix environment and with senior management. This is a key member of the GPS TA team. The Director has a major impact on drug development and commercialization decisions, strategies and operations, in all relevant territories globally.

In this role, a typical day might include the following:

With oversight from GPS TA Lead (Ex Dir of Sr Dir), responsible for all GPS activities for assigned compounds including and not limited to: signal management; responses to regulatory agency queries; preparation, review and finalization of safety documents (DSURs, PSURs, development RMPs, RMPs, etc); review and contribute to clinical documents (Investigator Brochures, protocols, clinical study reports, etc) focusing input on safety sections. Lead cross-function Safety Monitoring Team activities.

Represent GPS for assigned compounds on cross-functional teams, including but not limited to Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to Regeneron.

Proactively identify and develop plans/ strategies for non-compound specific Global Patient Safety activities. Resource for medical review of assigned compounds. Actively participate in the development and maintenance of relevant SOPs and working practices. Actively participates in continuous improvement activities within both the TA and the GPS organization

This role might be for you if:
  • You have the ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
  • Function as an SME internally and externally to GPS for assigned compounds.
  • Have the ability to utilize PVRM safety database for purposes of medical case review and simple queries.
  • Are able to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.
  • MD highly preferred.

We are seeking individuals with more than 4+ years total proven experience in GPS or equivalent including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with proven achievements in safety (ex. supporting an ISS; responsible for CSR content).

#MDJOBS

#MDJOBSPS

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

FacebookTwitterInstagramYouTube Logo

Find Us
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert