Senior Manager, Global Patient Safety Scientist
4 weeks ago
Job Summary:
The Senior Manager of Global Patient Safety will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. This position will be responsible for safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.
Key Responsibilities:
- Complete signal detection activities in line with approved safety surveillance plans.
- Perform signal evaluation for any identified signals and author safety evaluation reports.
- Manage preparation and review of safety documents, including DSUR, PSUR, RMP, and responses to health authority or other queries.
- Prepare and deliver presentations at Signal Management Team (SMT) meetings and participate in clinical study team meetings for assigned compounds.
- Participate in other risk management activities as appropriate for assigned compounds.
- Represent the Global Patient Safety team 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, such as the development and maintenance of relevant SOPs, WIs, and supporting documents.
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 queries.
- Able to be proactive and self-disciplined, meeting deliverables and effectively using time and prioritizing.
- Ability to effectively communicate (verbal and written) safety findings.
Education and Experience:
- Minimum a Master's, PhD, or PharmD.
- Offers 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority.
About Regeneron:
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.
Salary Range:
$145,400.00 - $237,200.00
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