Patient Safety Associate

Process Individual Case Safety Reports (ICSRs) from various sources, including data entry, coding (Medical Dictionary for Regulatory Activities [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 generation of safety metrics. Ensure accuracy, completeness, and regulatory compliance of safety data and documentation. Coordinate follow-ups, query management, and reconciliation activities with internal teams and affiliates. Support 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. Qualifications & Skills: Masters Degree in Life Sciences, Pharmacy, or related field or PharmD or BDS degrees. Eligible candidates: 2025 and 2026 graduates only. Basic knowledge of pharmacovigilance, ICH guidelines, and global safety reporting requirements. Strong attention to detail and analytical skills. Good communication, organization, and time management abilities. Proficiency in MS Office and familiarity with safety databases is advantageous. Ability to work effectively in a team and manage multiple tasks in a deadline-driven environment. Preferred Experience: Prior experience or internship in pharmacovigilance, clinical research, or healthcare setting is preferred. Experience Level Mid Level