※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Take full responsibility to prepare Japan Risk management Plan (J-RMP) and implement all activities related to risk management under GVP and GPSP in responsible products/compounds
Take full responsibility to create, implement and verify J-RMP including all risk minimization activities for 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 of responsible products/compounds.
- Take full responsibility to prepare and assess a summary of aggregate reports, revision of package inserts, Reexamination dossier, GPSP compliance inspection, Early Post-marketing Phase Vigilance, responses to regulatory inquiries, and others.
- Collaborate with members of JRML and PMSO for above mentioned activities in responsible products/compounds.
- Take a role as a core J-SMT member in collaboration with JPKK's key stakeholders including JCoT members in responsible products/compounds.
- In a way that supports JRML, liaise with all other internal and external key stakeholders of responsible products/compounds.
- Join related committee including partner companies as a representative of J-SMT of responsible products/compounds.
- Plan and monitor budgets and controls expenditures for responsible products/compounds in collaboration with JRML and Strategic Risk Communication Group.
- 5-year or more experiences in pharmaceutical industries are generally recommended.
- Scientific & medical knowledge including medical writing skill and local regulations, GVP and GPSP.
- Strong leadership including decision making, management, negotiation, stakeholder management and communication skills necessary.
- Ability/competency to show contentious proposals to responsible teams and groups.
- English communication skill (TOEIC 600 point and above), verbal, writing, presenting and facilitating.
- A BA degree in a biological or medically related field is preferred
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.