Job Description:
• Determining the category of information received i.e. whether it is a Medical Inquiry, Product Quality Complaint (PQC), an adverse event (AE) associated with a PQC, or an AE alone, and handling it accordingly per the relevant SOPs and guidelines
• Creating/generating AE/Product Complaint forms in the Product Complaint System
• Keeping track of the Product Quality Complaints
• Performing clear and accurate data capture of cases (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of cases in accordance with client conventions/guidelines and Standard Operating Procedures
• Reviewing ancillary documentation accompanying the reports and identifying the relevant information for processing and electronic capture in the applicable database
• Maintaining an excellent knowledge of case processing conventions and guidelines, client’s procedures and international drug safety regulations
• Maintaining a good working knowledge of the AE safety profile of assigned products and labeling documents
• Ensuring MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”, where applicable
• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Interacting with internal or external contacts to resolve issues related to the processing of cases and PQCs
• Responding to clients/customers in a timely manner
• Performing triage of literature abstracts and/or full articles for validity, if required
• Performing single case creation/initiation in the safety database, if required
• Mentoring new recruits in the team, if required
• Identifying areas of concern within the team and raising the issues with the Team Lead
• Maintaining an awareness of the performance metrics measured by client and striving to remain within established limits