Confirmation of Safety Coordinator case registry data
• Database searches as necessary
• Completion of literature searches as necessary
• Completion of remaining case data entry, including narrative or auto-narrative
• Completion of risk and quality (label, approval, manual coding & quality review steps)
• Clarification of unclear or illegible information from the LSO or Call Centre
• Discuss source documents, coding conventions and ad-hoc queries with Medical Assessment Physician
• Completion of protocol request forms as necessary
• Preparation of deviation memo as necessary
• Request deletions as necessary
• Single case unblinding

Education/Related experience:
• Registered Nurse OR
• Health/Biomedical Degree OR
• Licensed Practical Nurse with Bachelors degree OR
• Licensed Practical Nurse without Bachelors degree, but with knowledge of drug safety usually exhibited by minimum 5 years experience in pharmaceutical safety related role.
• Pharmaceutical Industry Experience Preferred

RELATED EXPERIENCE:
• Pharmaceutical industry experience
• Experience with a drug safety database
• Working knowledge of coding dictionaries
• Practical knowledge of global regulatory AE requirements
3 years experience in skills listed above