Job Description
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 assigned therapeutic area.
* Complete signal detection activities in line with approved safety surveillance plans
* 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 meetings; participate in clinical study team meetings for assigned compounds
* Participate in other risk management activities as appropriate for assigned compounds
Required Skills and Qualifications
* 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
* Minimum a Master's, PhD, or Pharm D
* 7+ years of relevant risk management experience in the pharmaceutical/biotech industry or health authority
Benefits
Regeneron offers an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs, fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves.
Others
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, or belief, 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.
Keyword: Safety