Job Title: Adverse Event Data Intake and ICSR Submission Specialist
About the Role:
This position reports to the Associate Director of Global Patient Safety (GPS) and is responsible for the initial intake of adverse event data via various channels. The role involves 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.
Responsibilities:
1. Lead a team responsible for intake and ICSR submissions for the company's product portfolio covering pre and post-marketing activities.
2. Serve as an ICSR submission subject matter expert on running small to large-sized studies/programs with moderate to sophisticated scope of work.
3. Contribute to intake responsibilities for Argus events and track and monitor ICSR timelines to ensure aligned submissions to regulatory agencies, collaborators, internal destinations, and contract research organizations (CROs).
4. Proactively investigate potential issues or noncompliance and raise trends and critical issues to management.
5. Lead investigations of non-compliance issues and identify root causes for late ICSR submissions.
6. Address and implement corrective actions related to ICSR submission activities.
7. Assist in managing and overseeing ICSR transmissions between the PV Intake Tool and Argus database and from collaborators to Argus database.
8. Proactively identify and lead continuous improvement/quality system initiatives through evaluation, development, and roll-out of process efficiencies applicable to all deliverables.
9. Author new and update existing SOPs and working instructions, and conduct related training.
Requirements:
1. Bachelor's degree in one of the life sciences or clinical research, Master's degree preferred, or licensed healthcare professional required.
2. Minimum 8 years of experience in drug safety and safety reporting in the pharmaceutical/biotech industry.
3. Strong knowledge and understanding of clinical research processes and global pharmacovigilance regulations, systems, and processes.
4. Extensive knowledge of the adverse event lifecycle.
We Offer:
A comprehensive benefits package that includes 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.