Contract Medical Reviewer
With oversight from Head of CERM, responsible for providing oversight to CRO individual case medical reviewers.
In this role, a typical day might include the following:
- Review all high impact cases (e.g. fatal/life threatening SUSARs, unanticipated events, cases where investigator and company causality differ, and others as required) prior to submission to health authorities.
- Provide medical advice and input to the activities of adverse event (AE) case management, including medical review of ICSRs (narrative, coding, labeling, causality, company comment) as well as work closely with PV teams, RM leads and clinical development leads to provide a cohesive, comprehensive and accurate medical narrative, analysis of similar events (when applicable) and company causality rationale in individual case reports prior to health authority submission.
- Serve as resource for medical review of Regeneron compounds.
- Skillful management and resolution of issues, which may, depending on complexity, require effective escalation.
- Actively participate in the development and maintenance of relevant SOPs and working practices
- Actively participate in process improvement activities within PV (as applicable)
This role might be for you if:
- Cinical experience, with 5 + years of industry experience in pharmacovigilance/ drug safety including significant previous experience in medical review of individual cases.
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.