Job Description
Reporting to the Associate Director of Global Patient Safety (GPS), this position is responsible for the initial Intake of adverse event data (i.e., via PV Intake Tool, electronic, fax, etc.). They will lead the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Collaborators and internal destinations in compliance with applicable global regulations (such as ICH-GCP, GVP VI) and contractual obligations. This role will lead a team responsible for Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities, serving as ICSR Submission subject matter expert (SME) on running small to large sized studies/programs that are moderate to sophisticated in scope of work with minimal guidance. In this role, a typical day might include the following: Contributing to Intake responsibilities for Argus events, in addition to all aspects of ICSR submission start-up process Tracking and monitoring of ICSR timelines to ensure that submissions to regulatory agencies, Collaborators, internal destinations and contract research organizations (CROs) are aligned. Proactively investigating potential issues or noncompliance and raises trends and critical issues where appropriate to Management. Leading investigations of non-compliance issues and identification of root cause for late ICSR submissions. Addressing and Implementing appropriate corrective actions related to ICSR submission activities. Assisting in the management and oversight of ICSR transmissions between the PV Intake Tool and Argus database and from Collaborators to Argus database. Proactively identifying and leading continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all deliverables. Authoring new and updates existing SOPs and Working Instructions, and conducts related training. This role might be for you if: You have a minimum of Bachelor's Degree, Master's Degree preferred, in one of the life sciences or clinical research and/or licensed healthcare professional required. Previous experience in drug safety and safety reporting in pharmaceutical/biotech industry is required with minimum of 8 years. Able to independently and expertly identify, analyze, and problem solve complex issues and trends. We are looking for people with strong knowledge and understanding of clinical research process and global pharmacovigilance regulations, systems, and processes. Extensive knowledge of the adverse event lifecycle. 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. 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.