Pharmacovigilance Services Senior Analyst

About the role

Accenture is seeking a Senior Analyst to join its Life Sciences R&D vertical, focusing on pharmacovigilance services. The role supports leading biopharma clients by ensuring the safety and regulatory compliance of pharmaceutical products through rigorous adverse event monitoring.

Key responsibilities

• Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow‑up for Individual Case Safety Reports (ICSRs) in the safety database.
• Prioritize and perform quality control (QC) of ICSR data based on client guidelines, regulatory due dates, turnaround times, service level agreements, and key performance indicators.
• Ensure accurate coding of medical history, drugs, and adverse event terms, and assess reports for seriousness, causality, expectedness, and labeling compliance.
• Collaborate with medical reviewers to resolve discrepancies and maintain data integrity throughout the pharmacovigilance workflow.

Required profile

• Bachelor or Master of Pharmacy.
• 5–8 years of experience in pharmacovigilance, drug safety surveillance, or related regulatory activities.
• Proven ability to prioritize work, meet deadlines, and adhere to quality standards.
• Strong understanding of global regulatory requirements for safety reporting.

Required skills

• Pharmacovigilance and drug safety surveillance.
• MedDRA coding and ICSR processing.
• Quality control (QC) of safety data.
• Regulatory compliance for adverse event reporting.

What we offer

• Opportunity to work with a global leader in professional services.
• Exposure to cutting‑edge life sciences projects and biopharma clients.
• Collaborative environment within Accenture’s Life Sciences practice.