01Overview
Roles & Responsibilities of Drug Safety Associate or Pharmacovigilance Associate
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 new 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: 30,691.91 - 45,340.48 per month
Benefits:
- Health insurance
- Provident Fund
Schedule:
- Day shift
Supplemental Compensation:
- Performance bonus
Experience:
- total work: 1 year (preferred)
Work Location: In person .
