Pharmacovigilance Officer – Veeda CR (Remote, India)

Veeda Clinical Research (Veeda CR) is hiring a Pharmacovigilance Officer for its growing drug safety and clinical research operations. This is a full-time, permanent remote job, with the hiring office located in Ahmedabad, Gujarat. The role is ideal for professionals with 2–3 years of experience in pharmacovigilance, SAE processing, and regulatory safety reporting.

This opportunity is highly relevant for candidates searching for pharmacovigilance jobs in India, remote PV officer roles, and drug safety jobs in CROs.

🔍 Key Responsibilities

Project Monitoring & Safety Management

• Support coordination of pharmacovigilance activities using project management tools.
• Prepare study safety documentation, including SAE Reporting Forms and completion guidelines.
• Develop training materials for investigator meetings and safety trainings.
• Provide progress reports, safety listings, and study-related updates to the PV Safety Manager (PVSM) and clients.

Pharmacovigilance Operations

• Assist in SAE and ICSR processing in compliance with protocols, SOPs, ICH-GCP, EMA, and FDA regulations.
• Maintain and update the internal safety database.
• Perform follow-ups with investigator sites for query resolution.
• Draft high-quality case narratives and ensure compliant documentation.
• Distribute reportable ICSRs to Ethics Committees, Investigators, and Marketing Authorization Holders (MAHs).
• Prepare and circulate 6-monthly SUSAR line listings to investigators.
• Support DSUR preparation and submission to Competent Authorities and Ethics Committees.
• Assist with MedDRA coding in coordination with Data Management and Statistics teams.
• Support additional pharmacovigilance departmental activities as required.

🎓 Qualifications & Skills

Educational Requirements

• UG: Any Graduate
• PG: Any Postgraduate (Life Sciences, Pharmacy, or related fields preferred)

Technical & Functional Competencies

• Strong knowledge of pharmacovigilance processes and SAE/ICSR reporting
• Hands-on experience with safety databases
• Working knowledge of MedDRA coding
• Understanding of ICH, EMA, and FDA pharmacovigilance guidelines
• Proficiency in Microsoft Office Suite and database tools
• Good communication and documentation skills

💼 Why Join Veeda CR?

• Opportunity to work in a global CRO environment
• Remote work flexibility with structured PV operations
• Exposure to regulatory safety reporting and international clinical trials
• Career growth in drug safety and pharmacovigilance

📨 How to Apply

Application Link