Patient Safety Associate II
Primary Location: India, Remote 求人ID R0000044642 Category Medical Affairs
About this Role
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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