Job Title: Pharmacovigilance Services Analyst
Company: Accenture
Location: Bengaluru, India
Job Type: Full-Time
Experience Required: 3–5 Years
Qualification: B.Pharm / M.Pharm
About the Role
Accenture is hiring a Pharmacovigilance Services Analyst to support global drug safety and pharmacovigilance operations. The role involves end-to-end Individual Case Safety Report (ICSR) processing, safety data review, MedDRA coding, case assessment, regulatory compliance, and collaboration with global safety teams.
This opportunity is ideal for professionals with prior pharmacovigilance case processing experience looking to build expertise in global drug safety surveillance and regulatory compliance.
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 and relevant dictionaries.
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 identification activities.
Regulatory Submission Support
Support timely case submissions to regulatory authorities.
Ensure adherence to regulatory timelines, SLAs, KPIs, and TAT requirements.
Required Skills
Pharmacovigilance Case Processing
ICSR Management
MedDRA Coding
Adverse Event Assessment
Drug Safety Surveillance
Regulatory Compliance
Medical Terminology Knowledge
Quality Review & Documentation
Attention to Detail
Time Management
Preferred Qualifications
Experience with Argus Safety, ArisG, PV-Works, or other safety databases.
Knowledge of FDA, EMA, MHRA, and global PV regulations.
Understanding of GVP guidelines and ICH standards.
Experience working in CRO, BPO, or pharmaceutical safety operations.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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China | Quarry Bay |Liaoning :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Tallinn |Hà Nội :
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