Pharmacovigilance Services New Associate
Location: Bengaluru, Karnataka, India
Company: Accenture
Employment Type: Full-Time
Job Summary
The Pharmacovigilance Services New Associate is responsible for supporting pharmacovigilance operations through case identification, adverse event processing, data entry, MedDRA coding, regulatory submissions, and follow-up activities. The role ensures Individual Case Safety Reports (ICSRs) are processed accurately and in compliance with client requirements, global pharmacovigilance regulations, and company procedures.
Key Responsibilities
ICSR Case Processing
Perform case identification and intake of adverse event reports from various sources.
Create and process Individual Case Safety Reports (ICSRs) within safety databases.
Ensure accurate and timely data entry according to client and regulatory requirements.
Review source documents and verify case information for completeness and accuracy.
Support case follow-up activities to obtain missing or additional safety information.
MedDRA Coding & Data Management
Perform MedDRA coding for adverse events, indications, and medical history information.
Maintain data quality and consistency within pharmacovigilance systems.
Validate entered data against source documentation.
Ensure adherence to data integrity and quality standards.
Regulatory Compliance
Process adverse event reports in accordance with global pharmacovigilance regulations and client-specific guidelines.
Support submission of safety reports to regulatory authorities within required timelines.
Maintain compliance with internal SOPs, regulatory requirements, and quality standards.
Ensure confidentiality of patient and company information.
Quality & Documentation
Perform self-quality checks on processed cases before submission.
Maintain complete and accurate documentation for all pharmacovigilance activities.
Support quality review and audit readiness activities when required.
Escalate case processing issues or compliance concerns to supervisors.
Team Collaboration
Collaborate with team members and supervisors to ensure smooth workflow management.
Participate in training sessions, team meetings, and process improvement initiatives.
Support operational goals while meeting productivity and quality targets.
Adapt to rotational shifts and business requirements as needed.
Required Qualifications
Education
Any Bachelor's Degree (Pharmacy, Life Sciences, Biotechnology, Nursing, Medical Sciences, or related disciplines preferred).
Experience
0–1 year of experience in Pharmacovigilance, Drug Safety, Clinical Research, Healthcare Operations, or related fields.
Freshers are encouraged to apply.
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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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
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 :
Breda |Noord Holland :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Mississauga | Uxbridge | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Buenos Aires |Republic of Egypt :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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