PHARMACOVIGILANCE SERVICES ASSOCIATE
Company: Accenture
Location: Chennai, India
Job ID: AIOC-S01650187
Department: Life Sciences R&D – Pharmacovigilance Services
Employment Type: Full Time
JOB OVERVIEW
The Pharmacovigilance Services Associate will support drug safety and pharmacovigilance operations by managing adverse event reports, Individual Case Safety Reports (ICSRs), MedDRA coding, case processing, submissions, and follow-up activities. The role ensures compliance with global regulatory requirements while contributing to patient safety and pharmaceutical product surveillance.
KEY RESPONSIBILITIES
• ICSR Case Processing
Create and manage Individual Case Safety Reports (ICSRs).
Perform case intake and case identification activities.
Enter adverse event information into safety databases.
Conduct MedDRA coding of adverse events and medical information.
Process safety cases according to client and regulatory requirements.
Review cases for completeness and accuracy.
Perform follow-up activities to obtain missing information.
• Pharmacovigilance & Drug Safety
Monitor and assess adverse event reports.
Support safety surveillance activities.
Assist in detection and evaluation of potential safety concerns.
Maintain compliance with pharmacovigilance regulations and guidelines.
Contribute to patient safety monitoring initiatives.
• Regulatory Reporting
Support preparation and submission of safety reports.
Ensure compliance with global reporting timelines.
Maintain accurate regulatory documentation.
Follow client-specific reporting procedures and workflows.
Assist with audit and inspection readiness activities.
• Data Management & Quality
Maintain high standards of data quality and accuracy.
Review source documents and case information.
Ensure data consistency across safety systems.
Support quality review and compliance checks.
Maintain complete and accurate records.
• Team Collaboration
Work closely with supervisors and team members.
Participate in training and development activities.
Escalate issues appropriately when required.
Support process improvement initiatives.
Contribute to team objectives and deliverables.
• Daily Operations
Solve routine operational issues using established guidelines.
Execute assigned work within defined timelines.
Manage workload efficiently in a regulated environment.
Work in rotational shifts when required.
REQUIRED QUALIFICATIONS
Bachelor of Pharmacy (B.Pharm)
Bachelor in Physiotherapy (BPT)
B.Sc Nursing
EXPERIENCE
1–3 Years of Experience
Experience in Pharmacovigilance, Drug Safety, Clinical Research, Healthcare, or related fields preferred.
Understanding of adverse event reporting processes is advantageous.
Knowledge of MedDRA and pharmacovigilance regulations is beneficial.
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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Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
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Remote, India | Siliguri |Illinois :
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Germany | GErmany |Lower Saxony :
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Saarbrucken |Switzerland :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
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