Patient Safety Associate II

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.