Patient Safety Associate I

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are seeking a detail-oriented Patient Safety Associate to support pharmacovigilance and drug safety operations across clinical trials and post-marketing activities. The role involves processing safety data, ensuring regulatory compliance, and contributing to high-quality safety reporting in accordance with global regulations and standard operating procedures (SOPs). **Key Responsibilities:** * 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:** * Master’s 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.