Pharmacovigilance Services Analyst – Accenture
Pharmacovigilance Services Analyst – Accenture
Company: Accenture
Role: Pharmacovigilance Services Analyst
Location: Chennai, India
Job Type: Full-time
Experience Required: 3–5 Years
Qualification: Bachelor of Pharmacy (B.Pharm) / Master of Pharmacy (M.Pharm) / BHMS
About Accenture
Accenture is a global professional services company providing consulting, technology, digital, cloud, and operations services across healthcare and life sciences.
Job Overview
Accenture is hiring a Pharmacovigilance Services Analyst for its Life Sciences R&D vertical. This role focuses on quality review, evaluation, and quality control (QC) of Individual Case Safety Reports (ICSRs) in global safety databases while ensuring compliance with client SOPs and international regulatory requirements.
Key Responsibilities
- Review and perform quality checks (QC) on Individual Case Safety Reports (ICSRs)
- Evaluate case accuracy, completeness, and regulatory compliance
- Review adverse event case processing in safety databases
- Validate seriousness, causality, and expectedness of adverse events
- Review medical history, lab data, therapy dates, and source documentation
- Perform case corrections, updates, deletions, and reprocessing where required
- Conduct follow-up for missing or incomplete safety information
- Escalate issues outside normal workflow to leads
- Perform root cause analysis (RCA) for case processing errors
- Document quality findings in QC tools/checklists
- Archive source documents and communications in global safety databases
- Support responses for regulatory authority safety requests
- Assist in transition/process improvement activities
- Work in rotational shifts
Required Skills
- Pharmacovigilance Operations
- Drug Safety Surveillance
- ICSR Quality Review
- Adverse Event Processing
- MedDRA
- WHO Drug Dictionary knowledge
- Safety Database Management
- Medical Terminology
- Medical Writing
- Regulatory Compliance
- Quality Control (QC)
- Root Cause Analysis (RCA)
- Data Validation
- MS Office
Preferred Experience
- 6 months to 1+ year relevant Pharmacovigilance experience mentioned in detailed JD
- Strong experience in:
- ICSR review
- Safety case processing
- Pharmacovigilance QC
- Medical coding
- Global safety databases
(Note: Header says 3–5 years, but detailed JD also mentions 6 months–1+ year relevant PV experience.)
Soft Skills
- Strong communication skills
- English proficiency
- Attention to detail
- Analytical thinking
- Quick learning ability
- Process discipline
- Team collaboration
- Problem-solving
