Global Pharmaceutical Company
- Manage and lead the J-GVP verification (final Adverse Event evaluation) staff members. Contributes to the resource planning and manage the workload balancing for the J-GVP verification case processing.
- Assess drug/device reportability and assign local labeling status (expected or unexpected) in order to achieve the appropriate case reporting status for Regulatory Agency reporting.
- Ensure medical plausibility, consistency and completeness of ADR (Adverse Reaction) / Malfunction case reports. Request follow-up information, and initiate use of specific product/event-related questionnaires when necessary.
- Provide input related to AE/SAE(Serious AE)/Malfunction case processing into global/local SOPs, global/local work procedures, the global/local user manual for the global database and other global/local process documents.
- Provide guidance on complex case handling issues which have been escalated by team members (if necessary involve medical subject matter experts)
- Ensure participation in global AE/SAE reporting compliance analysis appropriate corrective and preventive actions (CAPA) including corresponding documentation.
- Liaise with the global/local PV teams (e.g. Standards, Evaluation, SCPJ, J-Risk Management, J-PMS and J-medical governance) to support the definition of local specific needs for AE/SAE case evaluation.
- Bachelor's Degree or above
- A minimum of 5 years of Pharmacovigilance experience
- 8 years of relevant healthcare experience
- People management experience.
- Fluency in English (verbally and in writing). Must be able to fluently communicate with colleagues from PV data entry sites.
- Should have or quickly develop basic knowledge of ICH principles of AE/SAE 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.
- Proactive behavior and ability to keep timelines
- Incumbent must possess the ability to lead staff in changing times as well as strong interpersonal skills in the management and development of people in a changing environment 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.
- Ability to identify problems in case evaluation and to assist in the design workable solutions.
※Experiences and skills will be considered
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