Pharmacovigilance Services Analyst (Senior Drug Safety Associate)
Location: Bengaluru, India
Employment Type: Full-Time
Department: Pharmacovigilance Operations / Drug Safety
Experience: 3–5 Years
Qualification: B.Pharm / M.Pharm
Position Overview
We are seeking a detail-oriented Pharmacovigilance Services Analyst to support global drug safety and pharmacovigilance operations. The role involves end-to-end processing of Individual Case Safety Reports (ICSRs), including case intake, data entry, MedDRA coding, medical review support, case processing, regulatory submissions, and follow-up activities in compliance with global regulatory requirements and client-specific procedures.
The successful candidate will contribute to ensuring patient safety, regulatory compliance, and high-quality pharmacovigilance deliverables while working within a dynamic Life Sciences and Drug Safety environment.
Key Responsibilities
Case Processing & Safety Data Management
Perform end-to-end processing of Individual Case Safety Reports (ICSRs).
Review and validate safety information received from:
Healthcare Professionals (HCPs)
Consumers
Clinical Studies
Scientific Literature
Regulatory Authorities
Business Partners
Ensure accurate case intake, data extraction, and case creation within safety databases.
Perform case triage and prioritization according to client and regulatory requirements.
Adverse Event Reporting
Identify and process:
Adverse Events (AEs)
Serious Adverse Events (SAEs)
Adverse Drug Reactions (ADRs)
Product Quality Complaints (PQCs)
Special Situations
Assess case completeness and follow-up requirements.
Initiate and track follow-up requests to obtain missing safety information.
MedDRA Coding & Data Quality
Perform accurate MedDRA coding for:
Adverse Events
Medical History
Indications
Laboratory Data
Product Information
Ensure consistency and accuracy of coded data.
Conduct quality checks and resolve data discrepancies.
Regulatory Compliance & Submissions
Support preparation and submission of safety reports in accordance with:
Global Pharmacovigilance Regulations
ICH Guidelines
Good Pharmacovigilance Practices (GVP)
Client Standard Operating Procedures (SOPs)
Ensure adherence to reporting timelines and regulatory commitments.
Maintain inspection-ready documentation and audit compliance.
Safety Database Management
Enter and maintain safety data within validated pharmacovigilance databases.
Perform case reconciliation and data verification activities.
Support database cleanup and quality improvement initiatives.
Ensure complete and accurate documentation of all case activities.
Collaboration & Communication
Work closely with:
Drug Safety Teams
Medical Reviewers
Pharmacovigilance Physicians
Quality Assurance Teams
Regulatory Affairs Teams
Escalate complex cases and safety concerns to senior team members.
Communicate case-related updates and issues to supervisors as required.
Quality & Process Excellence
Follow established workflows, SOPs, and work instructions.
Contribute to continuous improvement initiatives within pharmacovigilance operations.
Support internal audits, inspections, and compliance activities.
Maintain high levels of productivity, accuracy, and quality metrics.
Required Qualifications
Education
Bachelor of Pharmacy (B.Pharm)
OR
Master of Pharmacy (M.Pharm)
Experience
3–5 years of experience in:
Pharmacovigilance Operations
Drug Safety
ICSR Processing
Adverse Event Reporting
Safety Database Management
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