Senior Business Analyst - Signal & Risk Management - Pharmacovigilance

Description:

Role Summary:

We are seeking a highly experienced Senior Business Analyst with deep expertise in Signal Management and Risk Management within Pharmacovigilance. The ideal professional will have strong domain knowledge, a solid understanding of ArisGs Advanced Signal Management solution, and proven experience supporting safety operations, process optimization, and system enhancements.

Key Responsibilities:

- Serve as the SME for Signal Detection, Signal Validation, Signal Assessment, and Signal Communication processes.

- Work closely with PV Operations, Medical Safety, and QA teams to refine and enhance signal workflows.

- Support configuration, requirement gathering, user stories, and documentation for ArisG Advanced Signals.

- Contribute to Risk Management activities, including Risk Management Plans (RMPs), mitigation strategies, and regulatory expectations.

- Facilitate cross-functional collaboration to ensure end-to-end alignment of safety processes.

- Lead UAT cycles, test planning, validation documentation, and release readiness.

- Drive process improvements and support overall PV system optimization.

- Conduct user training, knowledge transition, and communication across global teams.

Required Skills & Experience:

- 10+ years of experience in Pharmacovigilance / Drug Safety.

- Strong expertise in Signal Management business processes.

- Good understanding of ArisG Advanced Signals solution.

- Deep knowledge of Risk Management Plans (RMPs) and regulatory expectations.

- Strong analytical, documentation, and communication skills.

- Ability to work independently in a remote, global, cross-functional environment.

- Flexibility to work beyond standard hours when required.