Pharmacovigilance Services Sr Analyst

About the role

The Pharmacovigilance Services Senior Analyst will lead signal management activities and ensure the safety of pharmaceutical products through rigorous data analysis, reporting, and regulatory compliance. This role supports Accenture’s clients by monitoring adverse events, managing safety databases, and contributing to risk‑management strategies.

Key responsibilities

• Lead signal management activities, including weekly literature review and authoring SMART (Signal Management and Review Team) reports.
• Project‑manage Safety Surveillance Team meetings, ensuring timelines, accuracy and compliance with SOPs and global regulatory requirements.
• Create and manage case identification, data entry, MedDRA coding, processing, submission and follow‑up of Individual Case Safety Reports (ICSRs) in the safety database.
• Analyze complex pharmacovigilance data, identify emerging safety signals and support risk‑management decisions.
• Collaborate with internal Accenture peers, clients and management, providing clear communication and documentation.

Required profile

• Bachelor’s or Master’s degree in Pharmacy.
• 5–8 years of experience in pharmacovigilance or drug safety surveillance.
• Strong problem‑solving ability and attention to detail.
• Excellent written and verbal communication skills.
• Ability to work in rotational shifts and manage small teams or work streams.

Required skills

• Pharmacovigilance and drug safety surveillance.
• Signal management and literature review.
• MEDRA coding and ICSR processing.
• Safety database management.
• Preparation of SMART (Signal Management and Review Team) reports.