Facilitate patient access to company products in Japan through the following:
* Compliance with applicable local regulations;
* Development and maintenance of local business processes in pharmacovigilance (PV) and post marketing surveillance (PMS), integrated in relevant company processes;
* Development and execution of Japan risk management plan (J-RMP);
* Assessment of safety data in Japan; provision of safety expertise;
* Leading and collaborating on post marketing surveillance (PMS) activities
* Interface with regulatory agencies and industry organization;
* Alignment with key cross-functional partners and business partners;
* Continuous improvement of business processes.
As part of the Japan Safety organization, the Japan Safety PV Mgr is responsible for:
* Representing the local safety function in interactions with Regulatory agencies, other functions within AABP, staff members in Global Patient Safety, business partners, and external health care professionals, to achieve Safety objectives;
* Helping ensure compliant and efficient performance of local safety activities based on sound knowledge of local legislative requirements and practice, company policies and procedures; and
* Participating in exchange of safety information with stakeholders (company, partners, and external; local, regional, and global) to support informed understanding of product safety issues.
* This position reports to Japan Safety PV Sr Mgr