Patient Safety Associate I

Overview

Patient Safety Associate I role supporting pharmacovigilance and drug safety operations across clinical trials and post-marketing activities, on-site in Mohali.

What you'll do

• Process Individual Case Safety Reports (ICSRs) from various sources, including data entry, medical coding using MedDRA, narrative writing, and quality checks.
• Perform literature searches and reviews to identify potential adverse drug reactions and safety signals.
• Support safety submissions to regulatory authorities, ethics committees, and other stakeholders within required timelines.
• Assist in signal detection, compliance tracking, and the generation of safety metrics.
• Ensure the accuracy, completeness, and regulatory compliance of safety data and documentation.
• Coordinate follow-ups, query management, and reconciliation activities with internal teams and affiliates.
• Support the preparation of aggregate reports and maintain safety reporting schedules.
• Contribute to regulatory intelligence activities by tracking safety reporting requirements and updates.
• Participate in audits, inspections, and quality improvement initiatives as required.
• Collaborate with cross-functional teams and support client communication under supervision.

What you'll need

• Master's in Pharmacy, or a PharmD or BDS degree or Master's in a related field in Life Sciences.
• Eligible candidates are 2025 and 2026 graduates only.
• Basic knowledge of pharmacovigilance, International Council for Harmonisation (ICH) guidelines, and global safety reporting requirements.
• Strong attention to detail and analytical skills.
• Good communication, organization, and time management abilities.
• Ability to work effectively in a team and manage multiple tasks in a deadline-driven environment.

Nice to have

• Proficiency in Microsoft Office.
• Familiarity with safety databases.

Details

• On-site, based in Mohali.