Pharmacovigilance Associate

Celltrion Inc; Taguig; On-site; PHP 2,617,000 - 3,491,000; Full time

Job summary

A prominent pharmaceutical company is seeking a Drug Safety Associate in Taguig to manage Individual Case Safety Reports (ICSRs) and ensure regulatory compliance. Responsibilities include processing adverse event data, preparing safety reports, and supporting audits. Ideal candidates will have experience with safety documentation and a keen attention to detail. This full-time role offers a great opportunity to grow in the pharmaceutical industry.

Qualifications

• Experience in processing Individual Case Safety Reports (ICSRs).
• Knowledge of coding adverse events using MedDRA terminology.
• Familiarity with regulatory compliance and safety documentation.

Responsibilities

• Receive and process Individual Case Safety Reports (ICSRs).
• Ensure timely entry of adverse event data into the safety database.
• Assist in coding adverse events and verifying case accuracy.
• Support the preparation of safety reports and documentation.

Job description

Overview

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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

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