Patient Safety Administrator

INTRODUCTION

You will enter reports of drug side-effects from post-marketed or clinical study source to the safety database, and resolve queries related to pharmacy activities and individual case reports.

FUNCTION

Area of responsibility: Log and Data entry

• Ensure completion of basic training in case handling. Begin and complete the process for competency sign off for A category cases. Ensure that the case is QREd before closure in case the administrator is not signed off for A category cases
• Enter initial and follow-up information for individual adverse event case reports of low business risk onto the global Patient Safety database, using data interpretation, coding and writing skills in accordance with the current Data Entry Process Instructions and associated SOPs and OPI to ensure consistency of case entry and high data quality standards
• Select the cases from the relevant mailbox (Clinical trial, Post Marketed) and enter the Patient Safety Administrator person’s name in relevant field in mailbox tracker
• Begin to enter the case in Sapphire completing Log pages 1 and 2, save the information to generate case ID.
• Document the Sapphire case ID in mailbox tracker
• Assign the case to a case owner as per Global Case Handling SOP.
• Continue entering the case – if the Patient Safety Administrator has been signed off on category A cases – if it is required
• Perform all activities within the required timeframes to ensure regulatory compliance

REQUIREMENTS

• You have College or University Degree in biosciences or an appropriate healthcare or pharmaceutical industry background
• You have intermediate English language skill
• You have Basic competence with medical and therapeutic terminology
• You are a proficient user of Microsoft Office software