Tech-Functional Business Analyst – Signal & Risk Management (Pharmacovigilance)

Role Summary

We are looking for a highly experienced IT / Tech-Functional Business Analyst (12+ years) with deep expertise in Pharmacovigilance (PV) systems, specifically Signal Management and Risk Management modules. The role requires strong techno-functional capability to bridge business requirements with system design, configuration, integrations, and validation activities across the PV technology landscape.

Key Responsibilities

Tech-Functional Leadership

Serve as the

senior SME

for Signal Management and Risk Management platforms, with ownership of system functionality, enhancements, and solutioning.

Lead requirement workshops, system impact assessments, and end-to-end functional design for PV applications—primarily

ArisG Advanced Signals .

Drive solution architecture discussions with IT, vendors, and cross-functional stakeholders.

System Analysis & Delivery

Translate business needs into

high-quality BRDs, FSDs, user stories, data mapping specifications, integration requirements , and validation documentation.

Oversee configuration, release planning, change requests, and production deployments.

Conduct root-cause analysis, troubleshoot complex issues, and manage vendor escalations.

Support system upgrades, regression testing strategy, and UAT coordination.

Process Expertise

Deep understanding of

Signal Management processes

including detection, triage, validation, evaluation, prioritization, and aggregate reporting.

Good knowledge and hands-on involvement in

Risk Management Plans (RMP)

and associated PV risk mitigation workflows.

Ensure solutions comply with global PV regulations, audit requirements, and internal quality standards.

Collaboration & Governance

Act as a senior liaison between IT, PV operations, QA, and product vendors.

Prepare solution documentation, training materials, and system SOP updates as needed.

Provide mentorship / functional guidance to junior BAs and technical team members.

Required Skills & Experience

12+ years of total experience , with at least

8+ years in Pharmacovigilance IT / techno-functional roles .

Strong hands-on experience with

ArisG Advanced Signals

and PV safety systems.

Proven expertise in drafting system requirements, data flows, interface specifications, and functional design documents.

Strong understanding of compliance requirements (ICSR reporting, aggregate signaling, audit readiness).

Excellent verbal and written communication skills, with the ability to work with global stakeholders.