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...

A Pharmacovigilance Associate plays a crucial role in ensuring adherence to relevant regulations and standard operating procedures. They oversee processes to ensure the effectiveness of drugs while minimizing adverse effects in both research trials and hospital settings. **Responsibilities**: - recording and reporting adverse reactions received from...

**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...

**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...

**Company Description** We are PrimeVigilance (part of Ergomed Group), 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...

**Responsibilities for this position include**: - Identify out of scope activities in conjunction with the MSS Functional Lead - Determining the category of information received whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and...

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 -...

Key responsibilities: 1. Report and document adverse drug reactions 2. Enter safety data into databases 3. Assist in preparing regulatory reports 4. Review medical literature for drug safety updates 5. Support safety analysis and risk management - Minimal Customer interaction under guidance. - Understand domain Process/sub-process, functions, and...