Job Description :
MAIN TASKS AND RESPONSIBILITIES
• Promptly and accurately identify, interpret and extract adverse event and all relevant corresponding case information from a wide variety of source documents
• Enter the extracted information into the global database for serious and non-serious AE/ADR case reports.
• Identify information such as product technical complaints in the source documents, which must be further processed by the local affiliate, and forward accordingly.
• Adhere to internal data entry standards and specific timelines as prescribed by global regulations and SOPs.
• Create and review comprehensive medical case narratives with no important gaps regarding the reported information received. Confirm with experienced staff as needed.
• Verify, as prescribed by regulatory guidelines, that trade names are correctly translated into INN (International Non-proprietary Name).
• Perform accurate coding of incoming serious and non-serious adverse events and other case information using MedDRA terminology.
• Perform assessment of cases regarding the global listedness
• Enter drug-event relationship in non-serious and serious expected ADR/AE case reports as per company policies
• Ensure medical plausibility, consistency and completeness of ADR case reports and appropriate case level status with regard to regulatory agency reporting.
•To ensure completeness of ADR case reports, perform FU request
•Perform ADR case reporting to regulatory agency in line with local requirements and timelines
•Perform case processing related case rejections and reconciliation
•Upon alignment with an experienced Case Processor, request follow-up information for the completion of case reports making use of specific product/event-related questionnaires when necessary. Consult medical experts within TA group for advice in clinical questions
WHO YOU ARE
• Pharmacist, Veterinarian, Biologist, Nurse, HCP Life Science degree, or similar education with medical or scientific focus ideally with previous PV experience.
• Fluency in English (verbally and in writing) and Chinese. Must be able to fluently communicate with colleagues from PV data entry sites in other countries.
• Should be willing and able to quickly develop in-depth understanding of database field structure, and processing rules.
• Should have or quickly develop basic knowledge of ICH principles of SAE/AE reporting along with basic understanding of local and global regulatory rules and regulations and basic knowledge of safety policies and procedures in the major countries.
• Should have or quickly develop good understanding of AE and drug coding conventions (MedDRA, WHO-DD).
• Basic knowledge of standard office software packages (Word, Excel)
• High sense of responsibility and accountability and special sense for diligence even for routine processes
• Proactive behavior and ability to keep timelines
• Well established interpersonal skills. Excellent oral and written communication skills are essential
• Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology.
• Should possess well established decision-making and organizational skills, along with practiced training skills.
• Most important competences are drives results and manages complexity
• Should possess or quickly develop the ability to establish cooperative working relationships with staff from different cultural and medical backgrounds