Research Scientist Pharmacovigilance

Role & Responsibilities
• Perform duplicate checks, case triage, and accurate ICSR data entry as per global PV guidelines
• Conduct Quality Control (QC) activities including MedDRA and WHO-DD coding
• Prepare and review case narratives and perform expectedness and causality assessment
• Review and validate follow-up requests and ensure timely global regulatory submissions
• Allocate and manage case workflows to meet regulatory timelines and internal KPIs
• Ensure compliance with global PV regulations, SOPs, and organizational policies
• Mentor and guide team members to maintain high-quality safety standards
• Support audits, inspections, and continuous process improvement initiatives
• Perform additional pharmacovigilance tasks assigned by management

Qualification
• M.Pharm / Pharm.D (Mandatory)

Experience
• 1 to 2.5 years of experience in Pharmacovigilance / PV Operations
• Hands-on experience in ICSR processing and quality review preferred

Skills
• Strong knowledge of global PV regulations and ICH guidelines
• Proficiency in MedDRA and WHO-DD coding
• Narrative writing and causality assessment expertise
• Strong attention to detail and quality-focused approach
• Ability to manage timelines and regulatory compliance
• Good communication and teamwork skills

About the Company
The Fresenius organization operates within the global pharmacovigilance and drug safety domain, supporting regulatory compliance and safety case processing activities. Based in Gurugram, the company provides structured exposure to international PV operations, quality systems, and regulatory standards while fostering professional growth within a collaborative work environment.