Job Title: Data Officer – Pharmacovigilance (VAF 484)
Location: India (Remote Work Possible)
Department: Safety and Vigilance / Life Cycle
Employment Type: Permanent Contract
Experience Required: 1–3 years in Pharmacovigilance
Qualification: B.Pharm / M.Pharm
We are seeking a Data Officer – Pharmacovigilance to join our Safety and Vigilance team. This role ensures the optimized management of vigilance data, including safety, traceability, and integration into internal and client systems. The Data Officer also performs initial data analyses and supports pharmacovigilance reporting to internal teams, clients, and regulatory authorities. This position offers remote work flexibility while contributing to global pharmacovigilance operations.
Manage generic or client-specific email boxes related to pharmacovigilance.
Initial registration and triage of safety cases in internal tracking tools.
Conduct duplicate checks in safety databases (Client or PLG).
Enter vigilance cases, perform MedDRA coding, and write narratives, ensuring patient data anonymization where applicable.
Identify seriousness of cases and assess submission requirements in collaboration with medical personnel.
Draft follow-up emails, clarification requests, acknowledgments, and ensure timely case closure.
Submit clinical or post-marketing cases to Competent Authorities, Ethics Committees, partners, or affiliates as required.
Notify clients as per SDEA or Technical Agreements.
Generate reports and line listings from safety databases.
Analyze inclusion/exclusion of cases from EV or MHRA ICSR downloads.
Execute ad hoc database queries to support report generation.
Set up ICSR and MLM filters under Case Specialist guidance.
Download, search, and submit EV ICSRs.
Update XEVMPD records and perform initial submissions to MHRA, FDA, or other Competent Authorities.
Handle ICSR downloads and submissions for regulatory compliance.
Draft and update technical agreements, safety management plans, and client templates.
Develop and maintain SOPs, procedures, and operational documents related to pharmacovigilance activities.
Extract data for KPI calculation and prepare activity monitoring reports.
Support coordination of pharmacovigilance activities, ensuring timely communication and adherence to regulatory deadlines.
Provide weekly, monthly, quarterly, and yearly reports to clients.
Participate in audits to present pharmacovigilance activities.
Ensure proper implementation of division processes and compliance with internal and client requirements.
B.Pharm or M.Pharm degree.
1–3 years of hands-on experience in pharmacovigilance, safety data management, or regulatory reporting.
Proficiency in MedDRA coding and vigilance databases.
Understanding of ICSR processing, EudraVigilance, XEVMPD, and regulatory submission requirements.
Strong analytical, documentation, and reporting skills.
Excellent communication and organizational skills.
Ability to work independently and manage multiple tasks in a remote or on-site environment.
Be part of a global pharmacovigilance team contributing to patient safety and regulatory compliance.
Opportunity for professional growth and skill development in safety data management, regulatory submissions, and pharmacovigilance operations.
Work in a flexible, remote-friendly environment with exposure to global safety reporting standards.
Apply Now to join as a Data Officer – Pharmacovigilance (VAF 484) and advance your career in drug safety and vigilance operations in India.
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Auckland |New Zealand :
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Croatia |Zagreb :
Zagreb |Estonia :
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Kyiv |Lima Region :
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