Drug Safety Associate

Role & responsibilities

• Responsible for daily case processing of adverse event cases (clinical trial and/or post marketed), including coding using MedDRA, determining seriousness and expectedness at the event and case level.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Case downloading from regulatory authority websites
• Submission to applicable regulatory authorities within stipulated timelines
• Supporting and contributing to the development of training materials and training delivery.
• Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality, consistency, and accuracy as needed.
• Other duties as assigned

Preferred candidate profile

• Strong verbal, written and interpersonal communication skills.
• High level of accuracy and attention to detail.
• Excellent organization and prioritization skills; able to multitask.
• Basic knowledge of Pharmacovigilance.

Interested applicants can also apply directly with updated CV to hr@qpsbioserve.com