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...

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,...

**Key responsibilities of a Pharmacovigilance Associate**: - **Case Processing**:Receiving, reviewing, and processing individual case safety reports (ICSRs) from various sources like healthcare professionals, clinical trials, and patients. - **Data Entry and Management**:Accurately capturing adverse event details into specialized safety databases, including...

**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. -...

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. -...

**Job description** WHO defines Pharmacovigilance (PV) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Pharmacovigilance is also known as drug safety and it focuses on ADR (Adverse drug reaction).The main aim of Pharmacovigilance is to monitor approved...

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...

Perform case intake of Individual Case Safety Reports (ICSRs) from various sources (patients, healthcare professionals, literature, etc.).Enter and update safety data accurately in pharmacovigilance databases.Conduct initial assessment and triage of reported adverse events.Assist in coding medical terms using MedDRA.Ensure timely and compliant reporting of...

**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...