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AI Summary
Process and manage Individual Case Safety Reports (ICSRs) including data entry, coding, and narrative writing. Coordinate with global affiliates on safety reporting and support regulatory submissions and compliance tracking.
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 II
Key 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.
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