Manager Global Patient Safety Scientist

Regeneron ,
London, Greater London
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Job Description

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. Summary: Global patient safety scientist (GPS Scientist) will play a key scientific role in safety strategies for assigned products in clinical development and postmarketing. This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. Responsibilities: Perform signal detection activities for assigned products in line with approved safety surveillance plan Perform signal evaluation for any identified signals and author the safety evaluation report. Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other stakeholder queries etc Prepare and deliver presentations at SMT meetings; participate in clinical study team meetings as appropriate for assigned products. Participate in other risk management activities as appropriate for assigned compounds. May represent GPS for assigned compounds on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees 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. Requirements: Master's, PhD, or PharmD 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 or health authority. 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 GPS 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. To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. 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. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media. We do not interview candidates on Google Hangouts. Any questions about job listings can be directed to candidatesupport@regeneron.com. We also do not hire for "at-home data entry" positions. Employment Type: Regular Employee

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