Pharmacovigilance Associate
1 week ago
Overview Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Celltrion Inc Responsibilities Receive, record, and process Individual Case Safety Reports (ICSRs) from clinical trials, healthcare professionals, patients, and literature sources. Ensure timely entry of adverse event data into the safety database in compliance with regulatory timelines. Assist in coding adverse events using MedDRA terminology and verifying case accuracy. Support preparation of expedited safety reports and aggregate reports (e.g., DSURs, PSURs). Help maintain safety files and documentation in accordance with internal SOPs and regulatory requirements. Monitor literature sources for potential adverse event reporting. Provide administrative and operational support to the PV team, including safety data reconciliation with partners and CROs. Assist during audits, inspections, and regulatory queries by preparing necessary safety documentation. Participate in PV-related training and continuous improvement activities. Seniority level Associate Employment type Full-time Job function Quality Assurance and Research Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Celltrion Inc by 2x Get notified about new Drug Safety Associate jobs in Taguig, National Capital Region, Philippines . Manila, National Capital Region, Philippines 1 week ago Pharmacovigilance - Medical Information Call Center - Remote / US shift National Capital Region, Philippines 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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PE-Pharmacovigilance
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7 days ago
Taguig, National Capital Region, Philippines Celltrion Inc Full time ₱300,000 - ₱450,000 per yearKey ResponsibilitiesReceive, record, and process Individual Case Safety Reports (ICSRs) from clinical trials, healthcare professionals, patients, and literature sources.Ensure timely entry of adverse event data into the safety database in compliance with regulatory timelines.Assist in coding adverse events using MedDRA terminology and verifying case...
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