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...

**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...

**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...

**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. -...

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.,...

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,...

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...

Collect, review, and process adverse event reports from clinical trials and post-marketing sources. - Perform data entry of case details into safety databases accurately and within timelines. - Assist in coding adverse events, medical history, and medications using MedDRA and WHO-DD. - Support literature screening for identification of safety signals. -...