Data Officer – Pharmacovigilance (VAF 484)
Location: India (Remote / Hybrid options available)
Employment Type: Permanent, Full-Time
Function: Safety & Vigilance | Pharmacovigilance | Drug Safety
Career Level: Entry to Early Career
Role Overview
We are seeking a detail-oriented Data Officer – Pharmacovigilance to support end-to-end vigilance data management across clinical and post-marketing activities. This role is critical to ensuring accurate safety data processing, regulatory compliance, and effective integration of vigilance data across internal systems, client platforms, and global health authority tools.
The Data Officer will be responsible for the intake, processing, quality review, submission, and reporting of Individual Case Safety Reports (ICSRs), while supporting operational efficiency, traceability, and performance monitoring within the Safety and Vigilance function.
This opportunity is ideal for early-career pharmacovigilance professionals looking to build strong foundations in global drug safety operations.
Key Responsibilities
Vigilance Data Management
Manage generic and client-specific pharmacovigilance email inboxes.
Perform initial case intake, registration, and tracking within internal safety systems.
Conduct duplicate searches in client or internal safety databases.
Perform case triage, seriousness assessment, and data entry using MedDRA coding, including narrative writing and anonymization where required.
Identify seriousness criteria independently or with medical support using IME lists.
Prepare and manage follow-up communications, acknowledgements, and clarification requests.
Perform case closure in accordance with SOPs and regulatory timelines.
Submit clinical trial and post-marketing ICSRs to Health Authorities, Ethics Committees, Affiliates, and Partners as applicable.
Notify clients as per Safety Data Exchange Agreements (SDEA) or Technical Agreements.
Generate safety reports, summary tabulations, and line listings from safety databases.
Perform inclusion/exclusion analysis for cases downloaded from EudraVigilance (EV) or MHRA.
EudraVigilance & Regulatory Systems
Set up and manage ICSR and MLM filters under guidance from Case Specialists.
Download, review, and submit EV ICSRs and perform MLM searches.
Support XEVMPD updates and initial submissions to MHRA, FDA, and other regulatory authorities.
Conduct ICSR downloads and regulatory submissions to global health authorities as required.
Medical Writing & Documentation Support
Draft and update Safety Management Plans, Technical Agreements, and client templates.
Contribute to SOPs, work instructions, and operational procedures related to pharmacovigilance activities.
Additional Responsibilities
Extract safety data to support KPI calculations and performance monitoring.
Prepare periodic activity reports (weekly, monthly, quarterly, annual) for clients.
Support coordination teams to ensure regulatory timelines are met for expedited cases.
Participate in audits and inspections, presenting safety operations and documentation.
Support continuous improvement of safety processes and ensure effective implementation within the division.
Education & Experience
Bachelor’s or Master’s degree in Pharmacy (BPharm / MPharm).
0–2 years of experience in Pharmacovigilance, Drug Safety, or Safety Data Management.
Fresh graduates with relevant internships or safety database exposure are encouraged to apply.
Required Skills & Competencies
Strong understanding of pharmacovigilance concepts and ICSR lifecycle.
Familiarity with global safety regulations (EU, MHRA, FDA).
Knowledge of MedDRA coding and case processing workflows.
High attention to detail with strong data accuracy and documentation skills.
Ability to manage multiple cases with strict regulatory timelines.
Good written and verbal communication skills in English.
Ability to work independently and collaboratively in a remote environment.
Why Join This Role
Entry into global pharmacovigilance and safety operations.
Exposure to international regulatory systems such as EudraVigilance, MHRA, FDA.
Strong learning curve in safety databases, regulatory reporting, and compliance.
Long-term career growth in Drug Safety, Risk Management, and Regulatory Affairs.
Flexible work model with remote work possibilities in India.
This position offers an excellent opportunity to build a strong career in global pharmacovigilance and drug safety operations, contributing to patient safety and regulatory excellence worldwide.
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Pondicherry (Puducherry) |Jharkhand :
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Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Istanbul | Turkey |Norway :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western 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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Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | North York | Richmond Hill | Renfrew | Mississauga | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |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 :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Tel Aviv | Yavne | Netanya | Kfar Saba | Be'Er Sheva |Remote :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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