01Overview
Roles & Responsibilities of Pharmacovigilance
A Drug Safety Associate is a professional who works in the field of pharmacovigilance within a pharmaceutical, biotechnology, medical company or life sciences consulting firm. The main role of a Drug Safety Associate is to monitor the safety of drugs and medical devices once they are on the market and ensure that they are being used safely.
Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements.
Entering and maintaining adverse event information in safety databases
Narrative writing
Communicating with healthcare professionals and other stakeholders to gather additional information about adverse events
Assisting in the preparation of safety reports to be submitted to regulatory agencies
Monitoring safety literature to stay current on the latest safety information related to the company's products
Collaborating with other departments such as clinical research, regulatory affairs, and pharmacovigilance to ensure compliance with safety regulations and guidelines
Participating in the development and implementation of safety policies and procedures
Reviewing and assessing the safety profile of recent and existing products
Participating in the development and execution of risk management plans
Communicating with regulatory authorities, healthcare professionals, and other stakeholders on safety-related issues.
Job Types: Full time, Permanent, Fresher
Compensation: 25,064.34 - 35,471.11 per month
Advantages:
Health insurance
Paid sick time
Provident Fund
Work Location: In person .
