Pharmacovigilance Services Analyst
Location: Bengaluru, India
Job Type: Full-Time
Experience Required: 3–5 Years
Department: Pharmacovigilance Operations / Drug Safety
Company: Accenture
Job ID: AIOC-S01647840
Job Summary
The Pharmacovigilance Services Analyst is responsible for supporting drug safety and pharmacovigilance activities for global biopharmaceutical clients. The role involves case processing, adverse event management, MedDRA coding, data entry, case assessment, follow-up activities, and regulatory submissions in compliance with client requirements and global regulatory standards.
The successful candidate will contribute to ensuring patient safety through accurate and timely processing of Individual Case Safety Reports (ICSRs) while maintaining high quality and regulatory compliance standards.
Key Responsibilities
Pharmacovigilance Case Processing
Perform end-to-end processing of Individual Case Safety Reports (ICSRs).
Conduct case identification and triage activities.
Review source documents and extract relevant safety information.
Enter case data into safety databases accurately and within established timelines.
Perform medical coding using MedDRA terminology.
Assess and process adverse event reports according to client SOPs and regulatory requirements.
Conduct case follow-up activities to obtain missing or additional information.
Ensure timely submission of safety reports to clients and regulatory authorities as applicable.
Drug Safety Surveillance
Monitor and evaluate adverse event reports and safety information.
Support pharmacovigilance surveillance activities across clinical and post-marketing products.
Identify potential safety concerns and escalate issues appropriately.
Maintain compliance with global pharmacovigilance regulations and reporting requirements.
Ensure data accuracy, completeness, and consistency throughout the case lifecycle.
Quality & Compliance
Adhere to client-specific guidelines, SOPs, and work instructions.
Ensure compliance with:
Good Pharmacovigilance Practices (GVP)
ICH Guidelines
Global Regulatory Requirements
Company Quality Standards
Participate in quality review and quality improvement initiatives.
Support audit and inspection readiness activities.
Documentation & Reporting
Maintain accurate case documentation and audit trails.
Generate and update case-related records within safety systems.
Ensure all safety data is appropriately documented and archived.
Support preparation of reports and metrics as required.
Team Collaboration
Work closely with team members and supervisors to ensure timely case completion.
Collaborate with cross-functional teams to resolve case processing issues.
Participate in team discussions and knowledge-sharing activities.
Escalate complex cases and operational concerns to management when required.
Qualifications
Required
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
Experience Requirements
Required
3–5 years of experience in:
Pharmacovigilance
Drug Safety Operations
ICSR Processing
Adverse Event Case Management
Preferred
Experience handling global pharmacovigilance processes.
Experience working with safety databases.
Exposure to multinational pharmaceutical, biotechnology, CRO, or healthcare organizations.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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China | Quarry Bay |Liaoning :
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Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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