Global Safety Specialist

Description

• Receive, review, and ensure completeness of case information and source documents, performing duplicate checks and case triage.
• Accurately enter case data into the database, attach relevant documents, and perform MedDRA and WHO Drug Dictionary coding.
• Write case narratives, assess listedness and causality, and finalize case documentation for distribution/submission.
• Communicate with stakeholders for follow-up information and ensure compliance with follow-up procedures.
• Perform data validation, quality control, and reconciliation of cases, ensuring adherence to source data and procedures.
• Contribute to maintaining a robust medical device adverse event case handling process.
• Manage responsible areas, including new-to-market products and MHRA/EMA download and triage.

Qualifications

• PV experiance - 2 to 5 years
• Strong computer literacy and knowledge of safety databases
• Knowladge and experiance with EMA/ICH/FDA guidelines
• Ability to analyse and interpret data
• Good verbal and written English
• Experiance in case processing procedures
• Strong understanding AE/OE document practices and distribution methods (paper based and software)
• Good knowledge of medicine and pathology to apply in case triage and analysis