Pharmacovigilance Services New Associate
Company: Accenture
Location: Chennai, India
Department: Life Sciences R&D – Pharmacovigilance Operations
Job Type: Full-Time
Experience: 0–1 Year
JOB OVERVIEW
The Pharmacovigilance Services New Associate is responsible for supporting global pharmacovigilance operations by performing end-to-end processing of Individual Case Safety Reports (ICSRs), including case intake, validation, MedDRA and WHO Drug coding, adverse event assessment, narrative writing, regulatory submissions, and safety database management. The role ensures compliance with global regulatory requirements, client SOPs, and pharmacovigilance quality standards while contributing to patient safety and regulatory compliance.
KEY RESPONSIBILITIES
ICSR Case Processing
Perform end-to-end processing of Individual Case Safety Reports (ICSRs).
Prioritize, validate, and book safety cases received from multiple sources.
Conduct duplicate checks and verify case validity.
Process Adverse Events (AEs), Serious Adverse Events (SAEs), and SUSARs.
Ensure timely case completion according to regulatory timelines.
Safety Data Entry
Enter safety data into the Global Safety Database.
Extract relevant information from source documents.
Maintain accurate and complete case documentation.
Update safety cases throughout the processing lifecycle.
Ensure compliance with client SOPs and regulatory requirements.
Medical Coding
Perform MedDRA coding for adverse events.
Perform WHO Drug (WHODD) coding for suspect and concomitant medications.
Code medical history and relevant clinical information.
Ensure coding accuracy and consistency.
Follow global coding standards and client guidelines.
Adverse Event Assessment
Assess adverse events for seriousness, causality, and medical significance.
Evaluate safety reports using client procedures.
Consult Medical Reviewers when necessary.
Support safety signal monitoring activities.
Escalate potential safety concerns appropriately.
Case Narrative & Documentation
Draft and update case narratives.
Prepare E2B sender comments.
Maintain pharmacovigilance documentation.
Archive case communications and supporting documents.
Prepare meeting agendas and meeting minutes when required.
Regulatory Submission
Perform regulatory submissions of AEs, SAEs, and SUSARs.
Monitor submission status and resolve submission issues.
Review EVWEB and MHRA safety reports.
Support pharmacovigilance data reconciliation.
Ensure compliance with global regulatory reporting timelines.
Follow-up & Quality Assurance
Request additional or missing safety information.
Review responses and update safety cases.
Perform case corrections and case deletions as required.
Validate data consistency and perform quality checks.
Close pending follow-up actions within defined timelines.
Compliance & Operational Support
Participate in pharmacovigilance audits and inspections.
Support pharmacovigilance projects and cross-functional activities.
Monitor shared mailboxes and workflow queues.
Perform translations of source documents and narratives when applicable.
Complete all mandatory training and support business requirements.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor of Pharmacy (B.Pharm)
B.Sc. Nursing
EXPERIENCE REQUIREMENTS
Required
0–1 year of Pharmacovigilance or Drug Safety experience
Preferred
Knowledge of Global Safety Databases
Experience with MedDRA and WHO Drug Dictionary (WHODD)
Basic knowledge of Pharmacovigilance Operations
Medical terminology knowledge
Microsoft Office proficiency
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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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 :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
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 :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | North York | Renfrew | Richmond Hill | Australia | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Surabaya |Japan :
Saitama | Japan |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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