Senior Manager, Global Patient Safety Lead

4 weeks ago

Tarrytown, New York, United States Lifelancer Full time
Job Description

Reporting to the Associate Director of Global Patient Safety, this position is responsible for the initial intake of adverse event data and leading the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Collaborators, and internal destinations in compliance with global regulations 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, and serving as ICSR Submission subject matter expert on running small to large-sized studies/programs with minimal guidance.

Key responsibilities include:

  • Contributing to intake responsibilities for Argus events and all aspects of ICSR submission start-up process
  • Tracking and monitoring of ICSR timelines to ensure submissions to regulatory agencies, Collaborators, internal destinations, and contract research organizations (CROs) are aligned
  • Proactively investigating potential issues or non-compliance and raising trends and critical issues to Management
  • Leading investigations of non-compliance issues and identifying 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 updating existing SOPs and Working Instructions, and conducting related training

This role requires a minimum of 8 years of experience in drug safety and safety reporting in the pharmaceutical/biotech industry, with a strong knowledge and understanding of clinical research process and global pharmacovigilance regulations, systems, and processes.

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.

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.

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.

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.

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