Pharmacovigilance Services Associate

Role & Responsibilities:

• Perform end-to-end Pharmacovigilance case processing activities including case identification, data entry, MedDRA coding, case quality review, submission, follow-up, and case closure for Individual Case Safety Reports (ICSRs)
• Review and assess adverse event reports from various data sources such as clinical trials, spontaneous reports, literature, and post-marketing surveillance
• Ensure accurate and timely processing of safety cases in compliance with client SOPs, global regulatory requirements (ICH, GxP), and timelines
• Perform medical review support activities including seriousness, expectedness, causality assessment, and narrative writing as per guidelines
• Ensure data quality, consistency, and completeness in the safety database
• Support regulatory submissions to health authorities within defined timelines
• Collaborate with internal teams, supervisors, and quality teams to resolve routine issues and discrepancies
• Follow established processes, work instructions, and quality standards
• Manage individual workload efficiently and meet productivity and compliance targets
• Participate in training sessions and process improvement initiatives
• Work as an individual contributor within a team environment; role may require rotational shifts

Qualification:

• Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) from a recognized institution

Experience:

• 1-3 years of experience in Pharmacovigilance Operations, Drug Safety, or related Life Sciences roles
• Experience in ICSR processing and safety database handling preferred

Skills:

• Pharmacovigilance Operations
• Drug Safety Surveillance
• ICSR Case Processing
• MedDRA Coding
• Adverse Event Reporting
• Regulatory Compliance (ICH, GxP)
• Safety Database Management
• Attention to detail and analytical skills
• Good written and verbal communication skills
• Ability to follow SOPs and work instructions

About the Company:

Accenture is a global professional services company with leading capabilities in digital, cloud, and security, combining unmatched experience and specialized skills across more than 40 industries. Accenture provides Strategy and Consulting, Technology and Operations services.