The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases in the Oncology Solid Therapeutic Area. We will expect this to include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.
In this role, a typical day might include:
- Complete signal detection activities in line with approved safety surveillance plan.
- 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.
- 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 role might be for you if you can/have the:
- 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.
- Proactive and self-disciplined; able to meet deliverables, effectively use time and prioritize.
- Ability to effectively communicate (verbal and written) safety findings.
To be considered for this opportunity, you must have the following:
- Minimum a Master's, PhD, or PharmD.
- 8+ 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 step towards living the Regeneron Way!
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.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually) $145,400.00 - $237,200.00
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