Senior Business Analyst – Signal & Risk Management

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 ArisG’s 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.