安全性では、開発段階から市販後まで全てのノバルティスファーマの製品に対するファーマコビジランス活動を担っています。全ての情報源から収集した安全性情報を包括的評価に基づく安全性シグナルの特定、解析、適切な情報提供、並びに安全性リスクの管理業務を行っています。興味のある方は是非ご応募ください。

Your responsibilities include, but not limited to:
• Coordinate and/or conduct training and provide mentoring of Patient Safety Associates and other line functions/business units and vendors (e.g. Clinical Development, RA, Sales, Medical, GCO, etc).
• Work closely with the Head Japan Product Safety to allocate and monitor resource requirements including: coordinating activities involving the CO Patient Safety team, other line units, and/or contractors utilized to augment the regular Patient Safety staff. Activities may be related (but not limited) to administrative functions, training of other team members, or leading targeted drug-specific data collection efforts.
• Answer product related safety inquiries *(using approved information from the Japan Package Insert) to better educate HCP and enable them to make informed decisions regarding treatment for their patients
• Coordinate and/or contribute to all required Japan regulatory periodic reports, re-examination dossier.
• Support Global Medical Safety in monitoring the safety profile of product by raising attention to any potential issues or signals. Lead working groups when a safety issue occurs for investigation and assessment of the specific problem(s) and for the proposal and implementation of any action/change recommended and approved without undue delay
• Work with RA/PI to prepare for PVO’s responsible parts of labelling change
• Draft safety parts of J-CTD dossier including J-RMP

What you’ll bring to the role:3-5 Bullets
• Pharmacovigilance experience, knowledge and skills
Novartis Pharma K.K.からの続きを読む
Medical Advisor_Pharmacovigilance
Novartis Pharma K.K. 10日前
Digital marketing specialist
Novartis Pharma K.K. 4日前
Medical Advisor_Pharmacovigilance
Novartis Pharma K.K. 4日前

Japan Pharmacovigilance Expert

企業サイトでの申請
Back to search page
;