Senior Pharmacovigilance Study Operations Lead
We are currently looking for a fully remote Pharmacovigilance Operations Study Lead for a global pharmaceutical company on a 9 month contractual basis. This is a fully remote role with a high chance of being extended.
Key Responsibilities
* Case Management & Safety Data Oversight
* Lead the processing, review, and quality assurance of adverse event reports (ICSRs), ensuring compliance with global regulatory standards and internal protocols.
* Vendor and Compliance Management
* Oversee vendor performance in case processing, monitor KPIs, ensure quality control, and support compliance through training and regular audits.
* Process Optimization & Systems Support
* Improve pharmacovigilance workflows and systems by identifying process enhancements and contributing to SOP and policy development.
* Regulatory & Safety Reporting
* Prepare safety documentation for regulatory submissions, manage safety data accuracy, and respond to regulatory queries and audits.
* Cross-Functional Collaboration & Leadership
* Act as a liaison with clinical teams, mentor case management staff, support inspections, and lead operations in the manager’s absence.
Candidate Requirements
* Education: Bachelor’s degree in a health-related or biological science field (required).
* Experience:
* Proven background in pharmacovigilance/drug safety, with strong understanding of global AE/ICSR regulatory requirements.
* Familiarity with safety databases, MedDRA coding, and medical terminology.
* Experience managing vendor relationships and supporting audits/inspections.
Skills:
* Strong analytical, communication, and decision-making abilities.
* High attention to detail, organization, and time management.
* Proficient in Microsoft Office and safety database tools.
* Adaptable, collaborative, and capable of working in a dynamic environment.
* Willingness to work flexible hours as needed.