Patient Safety Associate II

Job description

**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. Patient Safety Associate IIKey Responsibilities - Process and manage Individual Case Safety Reports (ICSRs) including data entry, case assessment, MedDRA coding, narrative writing, follow-up, reconciliation, and quality checks. - Support regulatory safety submissions, periodic reports, and compliance tracking to health authorities. - Conduct literature searches and screening to identify adverse events, safety signals, and reportable cases. - Coordinate with global affiliates on safety reporting, local compliance requirements, translations, and data exchange. - Assist with regulatory support activities, product registrations, safety database updates, and regulatory intelligence monitoring. - Ensure adherence to SOPs, regulatory timelines, quality standards, and client requirements. - Participate in audits, inspections, process improvements, metrics reporting, and training activities. - Collaborate with cross-functional teams and support client interactions as required. Skills & Qualifications - Basic knowledge of Pharmacovigilance, drug safety regulations, ICH guidelines, and regulatory reporting. - Good understanding of medical terminology and safety databases. - Strong analytical, communication, organizational, and problem-solving skills. - Proficiency in MS Office and PV systems. Education & Experience - Degree in Life Sciences, Pharmacy, Biotechnology, Microbiology, Biochemistry, Dentistry, or related field. - 4+ years of experience in Pharmacovigilance, safety case processing, or regulatory reporting preferred.