Drug Safety Associate

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.

Key duties

• Adverse event reporting: Collect, evaluate, and report adverse drug reactions (ADRs).
• Data entry: Input and maintain safety data in databases.
• Regulatory compliance: Ensure compliance with drug safety regulations.
• Safety signal detection: Identify and assess potential safety risks.
• Documentation: Prepare and review safety-related reports.
• Collaboration: Work with clinical, medical, and regulatory teams on safety issues.

Job Type: Full-time

Pay: ₹450,000.00 - ₹800,000.00 per year

Benefits:

• Health insurance
• Internet reimbursement

Work Location: On the road