The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for cardiovascular and metabolism (CVM) products 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.
A typical day might include the following:
- Complete signal detection activities in line with approved safety surveillance plan for assigned molecules in cardiovascular and metabolism (CVM) molecules
- 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
This job 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
- 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
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides outstanding benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.