Safety & PV Specialist II - Literature Case Processing

Overview

Safety and PV Specialist II responsible for literature case processing and medical literature monitoring to identify and process adverse events within pharmacovigilance operations.

What you'll do

• Enter information into PV quality and tracking systems for receipt and tracking of ICSRs.
• Process literature-derived ICSRs according to SOPs and project-specific safety plans.
• Evaluate case data for completeness, accuracy, and regulatory reportability.
• Conduct data entry, coding, narrative writing, and follow-up activities as required.
• Perform comprehensive literature screening, review, and Medical Literature Monitoring (MLM) activities to identify and process potential adverse events.
• Maintain safety tracking systems and ensure timely completion of assigned activities and deliverables.
• Conduct MedDRA coding, drug coding, and maintenance of drug dictionaries as required.
• Perform quality review of ICSRs and ensure compliance with project and regulatory requirements.
• Identify, reconcile, and manage duplicate safety cases.
• Support validation and submission activities related to xEVMPD, SPOR, and IDMP requirements.
• Assist with manual recoding of products, substances, and indication terms when required.
• Ensure all relevant safety documentation is maintained and filed appropriately in accordance with company and client requirements.
• Maintain compliance with SOPs, Work Instructions, GVP, ICH-GCP guidelines, global safety regulations, and project-specific procedures.
• Participate in audits, inspections, and quality improvement initiatives as required.
• Apply regulatory intelligence and pharmacovigilance knowledge to safety processing and reporting activities.
• Foster effective working relationships with internal and external stakeholders and contribute to a collaborative team environment.

What you'll need

• 4-7 years of Pharmacovigilance experience, including significant experience in Literature Case Processing and Medical Literature Monitoring (MLM).
• M.Pharm, PharmD, B.Pharm, BDS, or equivalent healthcare-related qualification.
• Strong hands-on experience in ICSR processing, literature surveillance, data entry, narrative writing, and case management.
• Working knowledge of safety databases, MedDRA coding, and medical terminology.
• Good understanding of clinical trials, post-marketing safety requirements, ICH-GCP, GVP, and pharmacovigilance regulations.
• Experience in quality review activities and regulatory compliance processes.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Outlook, and other collaborative platforms.
• Ability to work independently and effectively within global teams.
• Excellent written and verbal communication skills.
• Strong organizational, analytical, and prioritization skills with the ability to manage multiple activities simultaneously.
• Detail-oriented with a high degree of accuracy and commitment to quality and compliance.

Details

• Location: Gurugram, India.