<p><strong>Your new role</strong>
Develop Patient Access in compliance with Pharmacovigilance (PV) and post marketing surveillance (PMS) while also developing Japan Risk Management Plan (J-RMP). Developing protocols and associated forms (e.g., questionnaires) for post-marketing surveillance activities (e.g., studies and surveys) in alignment with the Japan risk management plan from scientific and clinical aspects as well as points of the regulations.
<strong>What you'll need to succeed</strong>
Individual contributor as well as team manager with specific skills ensuring compliance with internal business procedures and applicable local regulatory requirements (e.g., GPSP, and Good Vigilance Practice [GVP]), including compliance related to interactions with medical institutions and healthcare professionals. Also need to track early post-marketing phase vigilance (EPPV) and dissemination of safety control information.</p>