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ProductLife Group (PLG), a global leader in regulatory affairs and pharmacovigilance services, is hiring a Data Officer for its remote India operations. This full-time opportunity is ideal for professionals with experience in pharmacovigilance data management, vigilance case processing, EudraVigilance, and regulatory submissions.
The Data Officer role focuses on optimized management of vigilance and safety data, ensuring regulatory compliance, traceability, and high-quality reporting across global safety databases and regulatory authorities.
🧪 Key Responsibilities – Data Officer (Pharmacovigilance)
🔹 Vigilance Data Management
- Manage generic and client-specific vigilance email inboxes
- Perform initial case intake, registration, and duplicate checks in safety databases
- Conduct triage, seriousness assessment, and MedDRA coding
- Draft case narratives, ensure anonymization of patient data
- Handle case follow-ups, acknowledgements, and closures
- Submit clinical and post-marketing ICSRs to regulatory authorities, ethics committees, partners, and affiliates
- Notify clients as per SDEA or Technical Agreements
- Generate line listings, summary tabulations, and database queries
🔹 EudraVigilance & Regulatory Submissions
- Set up ICSR and MLM filters as instructed
- Perform EudraVigilance ICSR downloads, MLM searches, and submissions
- Manage XEVMPD updates and submissions
- Handle MHRA, FDA, and other global authority ICSR submissions
🔹 Writing & Documentation Support
- Draft or update Safety Management Plans (SMPs) and technical agreements
- Support preparation of SOPs, operating procedures, and client templates
🔹 Reporting & Compliance
- Extract database data for KPI calculations
- Prepare weekly, monthly, quarterly, and annual activity reports
- Support audits and inspections by presenting vigilance activities
- Coordinate with internal teams to ensure regulatory timelines are met
🎓 Qualifications & Skills Required
- Degree in Pharmacy, Life Sciences, Biotechnology, or related field
- Experience in pharmacovigilance, drug safety, or vigilance data management
- Strong knowledge of ICSR processing, MedDRA, EudraVigilance, MHRA, FDA
- Familiarity with safety databases and regulatory submission workflows
- Excellent documentation, communication, and analytical skills
- Ability to work independently in a remote global environment
💼 Salary & Benefits
- 💰 Salary Range: ₹6,00,000 – ₹10,00,000 per annum (indicative, based on experience)
- 🏠 Work Mode: 100% Remote
- 🌍 Exposure to global regulatory and pharmacovigilance projects
- 📈 Career growth with a leading international life sciences consultancy
- 📚 Continuous learning and compliance-focused work culture
📩 How to Apply
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