Job Description
Regeneron is seeking a Medical Reviewer responsible for providing medical assessment and oversight of individual case safety reports completed by vendors and case processing resources in accordance with applicable regulations and agreements.
In this role, a typical day might include:
Ensuring that assigned staff are appropriately prepared to support current and anticipated activities for medical review and assessment of reports from global development programs and globally marketed products. Ensure inspection readiness and monitoring quality of the medical aspects of PV deliverables. Incumbent may have a supportive role in audits and health authority inspections.
In this role, a typical day might include:
With oversight from Lead Medical Reviewer, responsible for providing oversight to CRO individual case medical reviewers.
Review of all ICSRs including supporting vendor outsource model as directed by Lead Medical Reviewer.
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. Provides guidance to others within the team, across department and other functions.
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).
To be considered for this opportunity, you must have the following:
Clinical experience, at least 10+ years of experience in industry, and academia or patient care settings is required (may include Residency training and Fellowship training) Ability to apply and provide critical analysis of relevant clinical information for both clinical trial and post-marketing SAE and AESIs. Function as a medical review expert internal and external to GPS for Regeneron compounds. Ability to utilize GPS safety database for purposes of medical case review and simple queries.
Ability to effectively communicate (verbal and written) medical rationale and defend recommendations in safety narratives.
Strong clinical acumen with expertise in individual case reviews. Ability to manage external vendors and liase with Regeneron clinical and risk management team.
Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
Experience with Argus safety database
MD with 10+ years industry experience in pharmacovigilance/ drug safety including significant previous experience in medical review of individual cases
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Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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)