In support of TA Head and GPS Lead for the assigned compound, this role provides executional support on GPS results. This includes continuous safety monitoring, drafting and reviewing of safety documents to support ongoing regulatory activities, participating in cross functional discussion, and providing medical and safety expertise on safety related documents.
In this role, a typical day might include the following:
Review and provide safety input on periodic reports, dRMP, IB, protocols, informed consent forms, clinical study reports and other standard safety documents supporting clinical studies and other ongoing product development activities.
Perform signal detection and signal evaluation; and propose risk mitigation measures and implementation
Perform literature review for assigned Regeneron drugs and related products
Perform review of safety documents in support of market approval submissions, such as SAE narratives, patient profiles, and safety summaries.
Provide safety input on other safety related activities, such as REMS, RMP and RSOC (Regeneron Safety Oversight Committee) discussion.
This role might be for you if:
- We seek an advanced degree MD, PhD or PharmD Required
- Ability to apply and provide critical analysis of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
- We want you as a Function as a subject matter authority internal and external to GPS
- Ability to utilize GPS safety database for purposes of medical case review and simple queries.
- We expect you to effectively communicate (verbal and written) and defend safety findings and recommended risk management and minimization activities.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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