Pharmacovigilance

Roles & Responsibilities
• Identify and create safety cases in global safety databases
• Perform triage, case prioritization, and processing of AEs, SAEs, and SUSARs
• Conduct medical coding using MedDRA and WHO-Drug Dictionary (WHODD)
• Perform data entry and narrative writing in global safety systems
• Assess seriousness and causality as per client SOPs
• Submit safety reports within defined regulatory timelines
• Conduct duplicate checks and validation of case data
• Follow up for missing or incomplete safety information
• Handle E2B submissions and regulatory reporting requirements
• Translate source documents and case narratives where required
• Participate in audits and regulatory inspections
• Perform mailbox reconciliation and safety data tracking
• Ensure strict adherence to global pharmacovigilance regulations and compliance frameworks

Qualification
• B.Pharm (Bachelor of Pharmacy)
• BSc Nursing
• Bachelor’s Degree in Life Sciences

Experience
• 0–1 year of experience in Pharmacovigilance or Drug Safety (Freshers can apply)
• Basic understanding of global safety reporting requirements

Skills
• Knowledge of Pharmacovigilance and Drug Safety processes
• Familiarity with safety databases and case processing workflows
• Understanding of MedDRA and WHO-Drug coding
• Proficiency in MS Office applications
• Strong English communication and medical writing skills
• High attention to detail and accuracy
• Ability to meet strict timelines and quality KPIs

About the Organization
Accenture is a global professional services company specializing in digital, technology, and operations solutions. With a strong presence in life sciences and healthcare, Accenture supports global pharmaceutical companies through pharmacovigilance operations, regulatory compliance, and drug safety surveillance services.