Scientist, ICSR Management

Location: Basking Ridge, New Jersey, United States

Salary: USD 100,960–151,440 per year

Company

hirify.global is a global healthcare company developing innovative medicines across oncology, cardiovascular disease, rare diseases, and immune disorders.

What you will do

• Evaluate and submit adverse event reports in line with company policies and regulatory authority requirements.
• Support ICSR intake and processing, including data entry, reporter follow-up calls, and SAE reconciliation.
• Review daily bulk reporting, pending ICSRs, negative acknowledgements, and submission queries through resolution.
• Initiate system configuration requests, product approvals, and PVAs, and conduct User Acceptance Testing for change requests.
• Support CAPA investigations and collaborate with CRO management, data management, partner organizations, and cross-functional teams.
• Contribute to process guides, SOPs, training materials, and pharmacovigilance regulatory intelligence reviews.

Requirements

• Bachelor’s degree in nursing, pharmacy, or a healthcare-related field preferred.
• At least 1 year of pharmacovigilance experience and knowledge of FDA regulations required.
• Alternatively, 4+ years of pharmacovigilance experience may substitute for the education requirement.
• Experience with adverse event intake, ICSR processing, regulatory submissions, and compliance procedures.

Culture & Benefits

• Work within a global organization with a presence in more than 30 countries.
• Contribute to medicines intended to improve patient and public health outcomes.
• Equal opportunity and affirmative action employer.