Role Summary
We are looking for an experienced Senior Safety Business Analyst with strong expertise in Pharmacovigilance systems and business processes. The ideal candidate will have a deep understanding of Argus Safety, DLP activities, case processing workflows, and compliance reporting requirements.
Key Responsibilities :
- Act as the business SME for Safety systems and PV operations.
- Lead requirement gathering, documentation, and process mapping for Argus Safety, case processing, and safety reporting.
- Support system configuration discussions, enhancements, and workflow improvements.
- Ensure end-to-end compliance with ICSR reporting, regulatory submissions, and quality standards.
- Drive UAT planning, test scripts creation, execution support, validation, and change control.
- Work closely with PV, QA, IT, and Compliance teams to streamline safety workflows.
- Develop BRDs, FRS, User Stories, SOP / Work Instruction updates, and training materials.
- Support global teams and provide guidance on compliance expectations and best practices.
Required Skills & Experience :
10+ years of experience in Pharmacovigilance / Drug Safety.Strong understanding of Argus Safety, DLP processes, and Case Processing workflows.Solid understanding of compliance requirements (ICSR reporting, expedited submissions, regulatory timelines).Experience with documentation and process mapping (BRDs, FRS, BPMN flows, UAT scripts).Strong communication and stakeholder-management abilities.Ability to operate independently while working with global cross-functional teams.Flexible to manage meetings outside usual working hours.(ref : iimjobs.com)