Pharmacovigilance Services Senior Analyst
Job ID: AIOC-S01619340
Company: Accenture
Location: Bengaluru, India
Employment Type: Full-Time
Domain: Pharmacovigilance Operations | Drug Safety Surveillance
Experience Required: 5–8 years
Education: B.Pharm / M.Pharm / MSc (Life Sciences or related discipline)
About Accenture
Accenture is a global professional services organization with strong capabilities in digital, cloud, security, and intelligent operations. With more than 699,000 professionals across 120+ countries, Accenture delivers end-to-end solutions through Strategy & Consulting, Technology, Operations, and Accenture Song. Within the Life Sciences R&D vertical, Accenture supports global biopharmaceutical companies across clinical development, regulatory affairs, pharmacovigilance, and patient-centric services.
Role Summary
The Pharmacovigilance Services Senior Analyst will be part of Accenture’s Clinical, Pharmacovigilance & Regulatory sub-offering and play a critical role in ensuring patient safety and regulatory compliance. This position is suited for experienced pharmacovigilance professionals with hands-on expertise in ICSR case processing, MedDRA coding, and global safety database operations.
Key Responsibilities
Perform end-to-end ICSR case processing, including case identification, triage, and data entry.
Conduct accurate MedDRA coding, case narrative writing, and quality review activities.
Manage case submissions and follow-ups in global safety databases in accordance with client SOPs and regulatory timelines.
Monitor, evaluate, and analyze adverse drug reactions (ADRs) from multiple data sources such as clinical trials, literature, and post-marketing reports.
Ensure compliance with global pharmacovigilance regulations (ICH, GVP, FDA, EMA).
Resolve increasingly complex pharmacovigilance issues using established guidelines and analytical judgment.
Collaborate with internal teams, peers, and stakeholders, with occasional interaction with clients or Accenture leadership.
Support or oversee small work efforts or teams while contributing as an individual subject-matter expert.
Adapt to rotational shift requirements based on project and business needs.
Required Skills & Competencies
Strong knowledge of Pharmacovigilance Operations and Drug Safety Surveillance.
Proven experience in ICSR processing, MedDRA coding, and safety database management.
Understanding of clinical trial and post-marketing safety reporting.
Familiarity with global regulatory requirements and pharmacovigilance quality standards.
Ability to work independently with minimal supervision on routine tasks.
Strong analytical, documentation, and communication skills.
Experience & Qualification Criteria
5 to 8 years of relevant experience in pharmacovigilance operations or drug safety roles.
Educational background in Pharmacy or Life Sciences (B.Pharm / M.Pharm / MSc).
Prior experience in a Senior Analyst or equivalent role is preferred.
Why Join Accenture Life Sciences?
This role offers exposure to global pharmacovigilance programs, advanced safety systems, and complex regulatory environments. Accenture provides a structured career path, continuous learning opportunities, and the chance to contribute to patient safety on a global scale.
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