Job Title: Data Officer – Pharmacovigilance (VAF 484)
Location: India (Remote work possible)
Employment Type: Full-Time, Permanent
Department: Life Cycle – Safety and Vigilance
Experience Required: 0–2 years in Pharmacovigilance
Qualification: B.Pharm / M.Pharm
About the Role
We are seeking a Data Officer – Pharmacovigilance to support the optimized management of safety and vigilance data across internal, client, and regulatory systems. This role is critical in ensuring accurate data capture, traceability, integration, and reporting for clinical and post-marketing safety cases. The ideal candidate will contribute to the efficient organization of the Line of Business while supporting regulatory compliance and operational excellence.
Key Responsibilities
Vigilance Data Management
Manage generic or client-specific email inboxes for safety and vigilance communications.
Perform initial registration of vigilance cases into internal tracking systems.
Conduct duplicate searches and initial triage assessments in safety databases.
Enter case data accurately, including MedDRA coding, narrative writing, and anonymization of patient information.
Assess seriousness of cases using IME lists or support from medically qualified personnel.
Prepare initial follow-up emails, clarification requests, acknowledgments, and case closure.
Submit clinical and post-marketing cases to Competent Authorities, Ethics Committees, partners, or affiliates.
Notify clients according to requirements in SDEAs or Technical Agreements.
Generate line listings, tabulations, and reports from the safety database.
Perform inclusion/exclusion analysis for EV or MHRA ICSR downloads and prepare related queries and reports.
EudraVigilance (EV) Management
Set up ICSR and MLM filters under the guidance of Case Specialists.
Download, review, and submit ICSRs via EV, XEVMPD, and other regulatory systems (MHRA, FDA, etc.).
Conduct initial submissions and updates in compliance with regulatory guidelines.
Writing and Documentation Support
Draft and update technical agreements, safety management plans, and client-specific templates.
Maintain procedures, standard operating methods, and other documentation related to pharmacovigilance activities.
Additional Responsibilities
Extract database data for KPI calculation and performance monitoring.
Prepare activity reports for clients, including weekly, monthly, quarterly, and yearly updates.
Coordinate activities and communicate timelines to ensure regulatory deadlines are met.
Participate in audits and present activities as required.
Support the implementation and monitoring of division processes to ensure proper compliance and efficiency.
Required Qualifications & Skills
Educational Qualification: Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm).
Experience: 0–2 years in pharmacovigilance, safety data management, or related regulatory operations.
Strong knowledge of pharmacovigilance principles, GxP, and Good Clinical Practice (GCP).
Familiarity with safety databases, MedDRA coding, ICSR reporting, and EudraVigilance submission processes.
Excellent attention to detail, analytical skills, and organizational abilities.
Strong written and verbal communication skills for internal and client interactions.
Desirable:
Prior exposure to regulatory submissions (MHRA, FDA, EMA) or client-specific safety processes.
Experience in report generation, KPI tracking, and audit support.
Why Join Us
Opportunity to work remotely while contributing to global pharmacovigilance operations.
Gain hands-on experience in regulatory compliance, case management, and safety database operations.
Collaborate with multidisciplinary teams to ensure patient safety and regulatory excellence.
Build a strong foundation in life sciences safety and vigilance operations.
Application Instructions:
Qualified candidates with 0–2 years of pharmacovigilance experience are encouraged to apply. This is a full-time, permanent role with opportunities for growth in global safety and vigilance operations.
We are an equal opportunity employer and welcome applications from all qualified candidates in compliance with employment and regulatory laws.
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