Pharmacovigilance Associate

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...

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...

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...

A career in pharmacovigilance provides good prospects with generation of new drugs every day. Pharmacovigilance is the process of collecting, researching, monitoring, evaluating and assessing information derived directly or indirectly from patients. **Job Types**: Full-time, Regular / Permanent, Fresher **Salary**: ₹15,000.00 - ₹25,000.00 per...

Processing Individual Case Safety Reports (ICSRs) from all sources in compliance with applicable regulations, and in accordance with client specific requirements and timelines - Performing ICSR follow up - SAE/SUSAR Management (unblinding, clinical trial reconciliation, protocol review, Safety Management Plan review) - Reconciliation (clinical, partners) -...