Global Pharmaceutical Company
- Manage and lead a group of case processing staff members at entry site and work collaboratively with remote teams worldwide
- Supervise case processing of all types of Adverse Event reports from spontaneous as well as clinical trial and other organized data collection sources to ensure compliance with health authority requirements regarding ICSR handling.
- Supervise processing of Adverse Event reports from all Therapeutic Areas.
- Ensure proper handling of required follow-up attempts incompliance with required timelines as per SOP
- Liaise with Resource management function, Head SCP Japan & China, Global SCP Case Processing TA Heads and the SCP TA`s Case Processing Leaders in planning for long term and managing the acute resource needs for the area of responsibility, as well as workload balancing
- Supervise and manage the collaboration with external outsourcing partners.
- Liaise with the Case Processing Standards Leader and TA groups in maintaining and adapting standards for ICSR processing, providing input into global Quality Documents and PV-specific process documents and ensuring his/her group`s adherence to global case processing standards.
- Maintain and optimize processes for high quality, accurate and timely ICSR processing within his/her area of responsibility.
- Incumbent provides input in defining training needs for consistent and high quality case processing and ensures that appropriate training is received by his/ her reports.
- Ensures the correct medical coding of AE/SAE and drug terms. This requires in depth knowledge of the present coding systems (MedDRA and WHO-DD) with respect to structure and medical content.
- Analyze and provide regular feedback on QC - findings to individual staff members and define the evolving training needs for data entry personnel at the Osaka site and at CRO
- Provide guidance on complex medical and case processing issues which have been escalated by team members. This includes specific aggregate analyses and summary description of previous similar reports when required and identification of critical case reports that require immediate attention of a global Risk Management (RM) TAs.
- Provide medical/clinical advice for non-medic group members
- Participate in global AE/SAE reporting compliance analysis and assists in the definition of processes to improve case processing and evaluation. Ensure appropriate corrective and preventive actions (CAPA)including corresponding documentation.
- Ensures team contribution to the company's compliance with global Pharmacovigilance regulations and ensures timely and high quality input of standardized data into the continuous monitoring of safety profiles and resulting risk management activities of Bayer's medicinal products, which are key basic requirements to enable the approval and marketing of pharmaceutical products around the world.
- Ensure continuous monitoring of process efficiency and identification of opportunities for improvement without compromising compliance
- Significant contribution to Global Pharmacovigilance readiness for company internal audits and external health authority inspections
- University degree or above
- Over 6 years work experience in Pharmacovigilance (Drug Safety) functions preferable
- At least 3 years of experience with managing a team of 6 or more staff members
- 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.
- Must possess good medical/clinical interpretation skills based on potentially limited information provided along with a comprehensive understanding of medical terminology.
- Fluency in English TOEIC 800 and above (verbally and in writing) and Native Japanese. Must be able to fluently communicate with colleagues from PV data entry sites in other countries.
- 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
- Excellent oral and written communication skills are essential
※Experiences and skills will be considered
Business trip：Few times a year
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