Pharmacovigilance
About the Role
Roles & Responsibilities
• Perform Signal Detection and Signal Management activities for assigned products
• Conduct signal validation, prioritization, evaluation, and documentation
• Prepare and review Aggregate Safety Reports (PSUR, PBRER, DSUR)
• Analyze safety data from multiple sources including clinical trials and post-marketing surveillance
• Ensure compliance with global pharmacovigilance regulations and SOPs
• Collaborate with cross-functional teams for risk assessment and safety evaluation
• For Medics/Physicians: Provide medical review of safety cases and support benefit-risk assessment
Qualification
• MBBS / MD (for Medics/Physicians)
• B.Pharm / M.Pharm / Pharm.D / Life Sciences (for PV professionals)
Experience
• 4+ years in Signal Detection & Management
• Experience in Aggregate Safety Reporting
• 1+ year Pharmacovigilance experience (for Medics/Physicians)
• Freshers not eligible
Skills
• Strong knowledge of global PV regulations (ICH, GVP)
• Experience in signal detection tools and safety databases
• Expertise in aggregate report writing
• Medical review and benefit-risk evaluation skills
• Analytical thinking and data interpretation abilities
• Strong communication and stakeholder coordination skills
About the Company
Accenture is a globally recognized professional services company offering consulting, technology, and operations services across industries, including life sciences and pharmacovigilance. With a strong focus on innovation, digital transformation, and regulatory excellence, Accenture provides professionals with structured career growth, global exposure, and opportunities to work on large-scale drug safety programs.
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