Senior Business Analyst - Safety Systems - Argus/DLP/Case Processing

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.