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,scorecardsensure 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.