Senior Associate – Data Sciences - Global Market Vigilance (GMV)

Role Summary

We areseekinga highly analytical, data-driven Senior Associatewith hands on experience inpost-market surveillance,focus onproactivesignaldetection, regulatory compliance, safety data analytics, and global trend monitoring. This role requires mastery of end-to-end AE handling, advanced analytics, proactive signal detection, and the ability to work with fragmented datasets, ambiguous case information, and continuous inspection readiness.

Case Management & Compliance

• Lead/ perform AE intake, triage, and documentation in Veeva Vault Safety.

• Conduct duplicate checks and ensure data quality for analytics-readiness.

•Perform seriousness, causality, expectedness assessments with proper rationale.

• Ensure adherence to MedDRA coding standards, SOPs, and global AE reporting requirements.

Safety Data Analytics, Trending & Signal Detection

• Perform quantitative & qualitative analysis across markets&brands.

• Develop dashboards, KPIs,scorecards;ensure traceability and audit readiness.

• Drive global AE trending methodologies, detect andvalidatesafety signals and patterns.

• Conduct signal validation, case series, confounder assessmentetc.

•Identifyand work onautomating various activitiesendto endpharmacovigilance life cycle.

System & Process Optimization

• Support configuration, validation, and testing of safety database updates.

• Lead data audits, reconciliations, and root cause investigations.

• Implement improvements to enhance analytics readiness and data integrity.

Cross-Functional Collaboration & Leadership

• Serve as GMV analytics and safety point-of-contact for RA, R&D, Quality, Call Centers, CX.

• Present trends, risks, and signals in governance forumsor stakeholders.

• Mentor junior associates in analytics, casequalityanddocumentation discipline.

• Drive CAPAs related to safety data issues and monitor effectiveness.

Qualifications

• Bachelor’s/Master’s in Life Sciences, Pharmacy, or related field.

• 5–8 years ofdemonstrateddata analytics capabilityinPV/GMVspace.

• Experience withpharmacovigilance system preferablyVeeva Vault Safety or similar systems.

• Proven experience in trending, signal detection, dashboards, metric reporting.

Required Skills

•Deepknowledge of data analytics,trendingandsignal managementinPVspace.

• Hands-onsufferwith Power BI, Tableau, SQL, or advanced Excel.

•Go throughwith automation/AI-enabled PV intake/triage or analytics.

•Proactivelyreinforceaudit readiness, QMS, and vendor oversight. 

Key Attributes

• Exceptional analytical and critical thinking abilities.

• Ability to interpret noisy/fragmented datasets and create defensible insights.

•Strong communication& stakeholder management.

• Attention to detail and audit-ready documentation discipline.