Data Officer

🕒 6 days ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

Where this job comes from

Posted on ProductLife Group's careers page, not through a job board

First seen by Remote Rocketship 6 days ago

Logo of ProductLife Group

ProductLife Group

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

💊 Pharmaceuticals

💰 GROWTH EQUITY VC on 2024-04

Consulting • Healthcare • Pharmaceuticals

ProductLife Group is a global life‑sciences consulting and outsourcing firm that pairs deep human expertise with intelligent automation to help bring therapies and health products from development to patient access. The company provides end-to-end solutions across product development (pre-clinical to approval), regulatory affairs, CMC & quality, clinical development, engineering and facility construction, market & patient access, safety and compliance, and digital & AI-enabled innovation. ProductLife Group serves biopharma, medtech and consumer health clients, operates a global network of offices covering 150+ countries, and highlights ~1,750 experts and ~10k+ submissions per year.

📋 Description

• Manage shared and client-specific mailboxes • Register vigilance cases in internal tracking systems • Perform duplicate searches in safety databases • Conduct initial triage and data entry of vigilance cases • Code medical information using MedDRA • Prepare and update case narratives • Ensure patient data anonymization when required • Support follow-up requests and case closure activities • Assess case seriousness and submission requirements • Submit cases to Competent Authorities, Ethics Committees, Partners, and Affiliates as applicable • Generate reports and listings from safety databases • Perform database searches and data extractions • Support KPI calculations and activity monitoring • Prepare weekly, monthly, quarterly, and annual activity reports • Contribute to reconciliation activities and database quality checks • Support EudraVigilance activities, including ICSR downloads and submissions • Perform XEVMPD updates and submissions • Support MHRA, FDA, and other Health Authority reporting activities where required • Participate in the implementation of new client projects • Contribute to process optimization initiatives • Draft and update work instructions, technical agreements, and operational procedures • Support audits and inspections when needed • Maintain compliance with applicable pharmacovigilance regulations and company procedures

🎯 Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Dentistry, or a related scientific field • Experience in Pharmacovigilance, Drug Safety, Case Processing, Regulatory Affairs, or Database Management is an advantage • Knowledge of pharmacovigilance regulations and safety databases is preferred • Pharmacovigilance case processing • MedDRA coding • EudraVigilance knowledge • Database management and data entry • Microsoft Office Suite • Reporting and KPI monitoring • Regulatory compliance awareness • Strong attention to detail • Excellent organizational skills • Critical thinking and analytical mindset • Effective communication skills • Team-oriented approach • Ability to manage multiple priorities and deadlines

🏖️ Benefits

• Opportunity to work in an international Life Sciences environment • Exposure to global pharmacovigilance and regulatory activities • Professional development and career growth opportunities • Collaborative and dynamic working environment • Remote work arrangement

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