Pharmacovigilance Services Associate
Company: Accenture
Location: Chennai, India
Department: Life Sciences R&D – Pharmacovigilance Services
Job Type: Full-Time
Experience: 1–3 Years
JOB OVERVIEW
The Pharmacovigilance Services Associate is responsible for supporting global drug safety operations by performing Individual Case Safety Report (ICSR) processing, adverse event case management, MedDRA coding, safety database entry, regulatory submissions, and follow-up activities. The role ensures compliance with global pharmacovigilance regulations while contributing to patient safety and regulatory reporting.
KEY RESPONSIBILITIES
ICSR Case Processing
Identify and process Individual Case Safety Reports (ICSRs).
Perform case intake and case identification.
Create and maintain safety cases in the safety database.
Complete case processing according to client guidelines.
Perform follow-up activities for incomplete safety cases.
Pharmacovigilance Operations
Process adverse event reports from multiple sources.
Perform accurate data entry into the pharmacovigilance database.
Conduct MedDRA coding for adverse events.
Maintain case quality and completeness.
Ensure timely case completion within regulatory timelines.
Regulatory Compliance
Follow global pharmacovigilance regulations and client SOPs.
Support regulatory safety reporting requirements.
Ensure compliance with applicable global regulatory guidelines.
Maintain audit-ready safety documentation.
Adhere to quality and compliance standards.
Safety Database Management
Update safety databases with accurate information.
Validate case information before submission.
Maintain data integrity throughout the case lifecycle.
Track case status and submissions.
Support database quality activities.
Team Collaboration
Work closely with team members and supervisors.
Participate in daily operational activities.
Communicate case-related issues when required.
Support continuous process improvements.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor of Pharmacy (B.Pharm)
Bachelor in Physiotherapy (BPT)
B.Sc Nursing
EXPERIENCE REQUIREMENTS
Required
1–3 years of experience in Pharmacovigilance, Drug Safety, or Case Processing.
REQUIRED SKILLS
Pharmacovigilance
Pharmacovigilance
Drug Safety
ICSR Processing
Adverse Event Reporting
Safety Database Management
MedDRA Coding
Case Processing
Case Follow-up
Regulatory Reporting
Pharmacovigilance Compliance
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