Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Responsible for supporting Risk Management Leads in the successful conduct of risk management activities, including preparation of periodic safety documents (DSURs, PSURs, RMPs, etc) and conduct of safety signal activities. Serve as in-house subject matter resource for identified area(s), such as: relevant activities in assigned Therapeutic Area program(s).
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
6.Actively participate in the development and maintenance of relevant SOPs and supporting documents.
7.Actively participate in process improvement activities within PVRM.
BS, MS or Advanced degree in a scientific discipline required
Previous safety or relevant clinical experience in the pharmaceutical industy required, typically with at least 5 years of risk management or relevant clinical experience in pharmaceutical/ biotech industry.
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.
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.
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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.