Pharmacovigilance Services Specialist

About the role

Accenture is seeking a Pharmacovigilance Services Specialist to join its Life Sciences R&D vertical. The role supports global biopharma clients by ensuring drug safety data is captured, evaluated, and reported in compliance with regulatory standards.

Key responsibilities

• Create and manage case identification, data entry, MedDRA coding, and processing of Individual Case Safety Reports (ICSRs) in the safety database.
• Conduct safety data analysis from clinical trials, healthcare providers, and patients.
• Prepare and submit safety reports to regulatory authorities according to global requirements.
• Collaborate with cross‑functional teams and client stakeholders to resolve safety issues.
• Support continuous improvement of pharmacovigilance processes and tools.

Required profile

• Bachelor’s or Master’s degree in Pharmacy.
• 7–11 years of experience in pharmacovigilance or drug safety.
• Proven ability to handle moderately complex safety problems and develop solutions.
• Strong understanding of regulatory requirements for drug safety surveillance.

Required skills

• MedDRA coding.
• Case processing and management of ICSR data.
• Pharmacovigilance operations and drug safety surveillance.