Pharmacovigilance Associate

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...

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 training documents (i.e.,...

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...

Collect, review, and process individual case safety reports (ICSRs) from clinical trials, post-marketing, and spontaneous sources. - Perform medical coding using MedDRA and WHO-DD databases. - Enter safety data into pharmacovigilance databases (e.g., Argus, ARISg, Veeva Vault Safety). - Conduct case narrative writing and assessment of seriousness,...

We are seeking enthusiastic and detail-oriented freshers for the position of Drug Safety Associate. As a key member of our pharmacovigilance team, you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. This entry-level position is an excellent opportunity for recent graduates to start their careers in the pharmaceutical...

To write an effective drug safety associate job description, begin by listing detailed duties, responsibilities and expectations. We have included drug safety associate job description templates that you can modify and use. Sample responsibilities for this position include: Identify out of scope activities in conjunction with the MSS Functional...

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 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...

**Company Description** We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider initially 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,...