Drug Safety Associate

Job Description:

• 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.