Patient Safety Associate I (Pharmacovigilance)

Roles & Responsibilities
• Support global pharmacovigilance activities in line with regulatory requirements and Parexel SOPs
• Process Individual Case Safety Reports (ICSRs) including case creation, data entry, triage, follow-up, coding, narratives, and quality checks
• Monitor incoming safety reports from literature, EudraVigilance, mailboxes, and affiliates
• Perform literature searches, screening, and review for potential ADRs and safety signals
• Prepare and submit ICSRs and periodic safety reports to health authorities and other stakeholders
• Ensure accurate MedDRA coding, causality, seriousness, and expectedness assessment
• Support compliance metrics, late case investigations, and audit readiness
• Assist with safety submissions, unblinding, product/organization registrations, and reporting setup
• Coordinate with global teams, affiliates, and clients for safety data exchange
• Maintain documentation and archiving in EDMS/eTMF systems
• Participate in audits, inspections, training programs, and continuous learning

Qualification
• Degree in Life Sciences, Pharmacy, Biomedical Sciences, or related discipline
• Equivalent qualification or relevant work experience may be considered

Experience
• Freshers or candidates with experience in pharmacovigilance, drug safety, or healthcare environments
• Prior exposure to ICSR processing, literature review, or regulatory reporting is an advantage

Skills
• Basic knowledge of pharmacovigilance and drug safety regulations
• Understanding of ICH guidelines and global regulatory requirements
• Strong documentation, analytical, and problem-solving skills
• Good written and verbal communication skills
• Ability to work in a regulated, timeline-driven environment
• Familiarity with pharmacovigilance databases and MS Office tools
• Willingness to learn and grow in a global CRO setup

About the organization
Parexel is a leading global clinical research organization committed to improving world health by supporting the development of life-changing therapies. With expertise across clinical trials, regulatory, and safety services, Parexel partners with biopharmaceutical companies worldwide to deliver high-quality, patient-focused solutions.