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