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...

Pharmacovigilance is the most precise way for evaluation of the relevancy of Clinical Research. In this the tests are conducted under observation whether a new innovative product performs as expected or not. There is ‘n’ number of innovative therapies generated in laboratories but very few of them survive & reach to the point of human testing. It...

As a Pharmacovigilance Associate you are part of the Pharmacovigilance Department (sometimes called the Drug Safety Department). Your role is one of reporting adverse effects (AEs) and side effects, in accordance with the current Dutch and European legislation for pharmacovigilance. You may also train colleagues in departments such as marketing and sales,...

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...

**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...

**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...

Pharmacovigilance is the process of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications to ensure that drugs on the market are safe for patients and to identify new hazards associated with the medication. **Job Types**: Full-time, Regular /...

Pharmacovigilance is the process of collecting,monitoring resarching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications to ensure that drugs on the market are safe for patients and to identify new hazards associated with the medication. **Job Types**: Full-time, Regular / Permanent **Salary**:...

**Writing generic RMPs (data collection, Log of changes preparation, validation of finalised RMP)**: - **Coordinating simple generic RMPs** - **Drafting of responses to requests from regulatory agencies concerning RMP, as needed**: - **Ensuring that all tasks are performed in line with relevant predefined procedures**: - **Cooperation with other other...

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,...