Pharmacovigilance Associate

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...

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...

**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...

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**:...

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...

**Roles and Responsibilities for Pharmacovigilance** - In this role, you are required to solve routine problems, largely through precedent and referral to general guidelines - Your primary interaction is within your team and your direct supervisor - You will be given detailed instructions on all tasks that need to be carried out, and the decisions that you...

A Drug Safety Associate is responsible for assessing the safety of pharmaceuticals drugs once they're on the market. Using standardised guidelines, they determine whether the medication causes any adverse reactions in patients and report their findings back to the pharmacovigilance department. **Job Types**: Full-time, Regular / Permanent,...