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Director of Pharmacovigilance and Safety Science
2 months ago
The Associate Director, Pharmacovigilance Scientist will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead. This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate safety messaging and benefit-risk assessments.
Key Responsibilities- Signal Detection and Evaluation: Complete signal detection activities in line with approved safety surveillance plan, perform signal evaluation for any identified signals, and author the safety evaluation reports.
- Safety Document Management: Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries.
- Presentations and Team Collaboration: Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds.
- Risk Management and Cross-Functional Teams: Participate in other risk management activities as appropriate for assigned compounds, 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.
- Process Improvement: Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents.
- Education and Experience: Master's, PhD, or PharmD (preferred), 10+ years of relevant safety related experience in the pharmaceutical/biotech industry or health authority.
- Skills and Qualifications: Apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments, work with a safety system database, prioritize and multitask to meet deliverables, effectively communicate (verbal and written) safety findings.
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.
