- From investigational phase through post-marketed phase, take full accountability to provide functional expertise, leadership, support, and assistance to cross-functional teams and managements to achieve functional goals and objectives.
- Take full accountability to prepare Japan Risk Management Plan (J-RMP) and implement all activities related to risk management under the relevant regulations in responsible products/compounds and cover multiple products/compounds.
- Take full accountability to create, implement and verify J-RMP activities including EPPV, risk communication activities and aggregate reporting such as J-DSUR, J-PSUR, Periodic Infection Report and Non-serious unlisted periodic report including reports for medical devices and all activities related to Post-Marketing Surveillance/Clinical study/Database research.
- Take full accountability to prepare Re-examination dossier and GPSP compliance inspection in responsible products/compounds.
- Lead and manage PvA and PMSO in responsible products/compounds.
- Lead and facilitate J-SMT meeting in collaboration with JPKK’s key stakeholders including JCoT members.
- As an extended member of Global Safety Management Team(G-SMT), liaise with G-SMT of responsible products/compounds. Join JCoT, NPI and other related committee with license partner companies as a representative for J-SMT of responsible products/compounds and proactively lead safety risk management related discussions and take necessary actions by covering early stage of clinical development though postmarketed phase of products.
- Lead and contribute to the prevention and rapid resolution of local safety risk management related issues including timely stake holder management (internal and external) of responsible products/compounds.
- Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with Group manager/ Director.
- Contribute to the implementation of continuous process improvements from advanced safety management point of view by utilizing latest technologies while enhance sustainable efficiency in collaboration with SPMD.
- Understand the rule and principle of the relevant regulations such as PMD Act., GCP, GVP and GPSP and ensure compliance to those regulations, within own responsibility.
- 3-4year or more experiences in pharmaceutical industries are generally recommended.
- Scientific & medical knowledge including local regulations, GCP, GVP & GPSP.
- Must have strong leadership including decision making, management, negotiation, and stakeholder management and communication skills necessary.
- English reading and writing skill (TOEIC 700 is preferred)
Johnson & Johnson Family of Companies in Japan strongly recommends prospective employees to complete the COVID-19 vaccination before or as soon as after joining our company to prevent the spread of infection among our employees and people around them as well as our customers and the community we serve, and to ensure our responsibilities are sustainably fulfilled as a healthcare company (except for those who cannot vaccinated with underlying medical conditions and other circumstances).