Pharmacovigilance Associate

A pharmacovigilance associate ensures compliance with applicable regulations or standard operating procedures; specialises in drug safety management, clinical trials and medical supervision. - Responsible for conducting, monitoring or reporting regular pharmacovigilance developments and supervising the processes related to ensuring drug effectiveness and...

1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. - Ensure appropriate interpretation...

**Primary Responsibilities**: 1. General Responsibilities and Regulatory Compliance: - Execute pharmacovigilance activities as nationally required (e.g. adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File). - Monitor national pharmacovigilance legislation. -...

Collect, review, and process adverse event reports from healthcare professionals, patients, and clinical studies.Enter and maintain accurate case data in safety databases.Perform case assessment and narrative writing under supervision.Assist in the preparation of Individual Case Safety Reports (ICSRs) and follow-up activities.Support signal detection and...

**Key Responsibilities**: - **Case Management**: - Receive, document, and assess adverse event reports from various sources, including healthcare professionals, consumers, and regulatory authorities. - Ensure accurate and timely data entry of adverse event information into the safety database. - Conduct thorough case investigations and follow-up activities...

**Responsibilities**: - Process and assess individual case safety reports (ICSRs) - Enter and manage safety data in databases - Perform quality checks on safety reports - Assist in preparing regulatory reports (e.g., PSURs, DSURs) - Support signal detection and risk management activities **Skills Required**: - Knowledge of pharmacovigilance regulations...

**Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...

**Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...

Perform case intake and data entry into safety databases (e.g., Argus, ArisG). - Assist in triaging and prioritizing cases based on seriousness and timelines. - Perform quality checks to ensure accuracy and completeness of information. - Collect and process adverse event (AE) reports from healthcare professionals, patients, and regulatory authorities -...

**Company Description** We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...