Job description:

To participate in adverse event case management, clinical management activities and evaluate AE reports to ensure drug safety.

• To assist with the preparation of adverse event reporting plans (AERPs), participate in quality assessment reviews, audits and engage in gap analysis for SOPs
• To be responsible for quality levels and revision rates of client to include all aspects of client revisions including running reports, completingorassigning revisions, compiling data, developing strategies to reduce revisions, mentoring staff on revisions, and communicating revision information to the client.
• To partner with Program Manager in communicating key issues and milestones to the stakeholders, and ensure that all internal and client-specific activities are performed in compliance with regulatory requirements.
• To perform literature review for identification of case reports and relevant safety information, prepare training materials specific to safety and mentor and train neworexisting staff on client requirements.
• To process and evaluate AE reports according to the customer's standard operating procedures (SOPs), ensure quality and accuracy of data and assist in the reconciliation of clinical and safety databases.