Job Title: Pharmacovigilance Services Associate
Company: Accenture
Location: Bengaluru
Job Type: Full-Time
Experience Required: 1–3 Years
Qualification: B.Pharm / M.Pharm
About the Role
Accenture is hiring a Pharmacovigilance Services Associate to support global drug safety and pharmacovigilance operations. The role focuses on end-to-end Individual Case Safety Report (ICSR) processing, adverse event assessment, MedDRA coding, safety database management, and regulatory compliance. This position is ideal for professionals looking to build a strong career in global pharmacovigilance and drug safety surveillance.
Key Responsibilities
ICSR Case Processing
Perform case intake, triage, validation, and booking of safety cases.
Review source documents and identify valid adverse event reports.
Conduct duplicate checks and maintain case quality standards.
Process Individual Case Safety Reports (ICSRs) according to client and regulatory requirements.
Data Entry & Safety Assessment
Perform accurate data entry into safety databases.
Code adverse events, medical history, and concomitant medications using MedDRA.
Assess seriousness, causality, expectedness, and reportability of cases.
Escalate medically significant cases to Medical Reviewers when required.
Narrative Writing & Follow-Up
Prepare and update case narratives.
Determine follow-up requirements and initiate follow-up activities.
Maintain complete and accurate case documentation.
Quality & Compliance
Conduct self-QC and consistency checks before case completion.
Ensure compliance with global pharmacovigilance regulations and client SOPs.
Support safety monitoring and signal detection activities.
Archive case-related communications and documentation.
Regulatory Submission Support
Support timely case submissions to regulatory authorities.
Ensure adherence to regulatory timelines, TAT, SLAs, and KPIs.
Maintain data accuracy and submission readiness.
Required Skills
Pharmacovigilance Case Processing
ICSR Management
MedDRA Coding
Drug Safety Surveillance
Adverse Event Assessment
Safety Database Management
Medical Terminology
Regulatory Compliance
Quality Review
Documentation Management
Attention to Detail
Time Management
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