Job Description

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