Pharmacovigilance Services Specialist

Role & Responsibilities
• Perform medical review of Individual Case Safety Reports (ICSRs) for seriousness, causality, labeling and MedDRA coding
• Ensure accurate and timely safety case processing in line with global regulatory timelines and client SOPs
• Review source documents and narratives for medical accuracy and database consistency
• Write company causality comments and route cases through workflows as per SOPs
• Validate E2B reporting and perform self-quality checks before case finalization
• Lead internal and cross-functional trainings and mentor team members
• Handle medical assessment queries, case follow-ups and regulatory clarifications
• Support PV compliance, audits, inspections, documentation archiving and process transitions

Qualifications & Experience
• MBBS / MD
• 7–11 years of experience in Pharmacovigilance / Drug Safety medical review

Skills
• Strong medical writing and safety narrative skills
• Expertise in MedDRA, WHO-Drug, ICSR processing and global PV regulations
• Proficiency in safety databases and MS Office
• Excellent English communication skills

About the Company
• Accenture is a leading global professional services company specializing in strategy, consulting, digital, technology, and operations.