The Safety Physician is responsible for:
1) Support of R&D Program, NDA submission and Product Launch
- Support R&D programs, NDA submission and product launch in Japan from safety perspective, in close collaboration with local other functions and GPS team (global Safety Physicians and global Safety Scientists).
- Represent GPS Japan on local cross-functional teams for development compounds/products, including e.g. Japan Project Team, Submission Team, Launch Team, ensuring that all agreed safety deliverables and deadlines for safety contributions are met.
- Contribute to the discussion for portfolio management from safety perspective, if applicable
- Deliver safety aspects to clinical trial activities as appropriate; for example, clinical study protocols /reports/Investigator’s Brochure etc. in particular for local Japanese and regional studies.
- Contribute to set up Clinical Trial Safety Management processes and review safety parts in documents related to outsourcing of trials (e.g. CRO contracts, Request for Proposals and Service Agreements with CROs, for local Japanese and regional studies.), where applicable;
- Attend Investigators meeting, if applicable.
- Contribute to preparation of safety parts of submission dossiers to be submitted to PMDA (e.g. CTD 2.7.4, 2.7.5 and 1.11 including J-RMP) and contribute to answers for inquiries from PMDA/MHLW, closely interacting with relevant global Safety Physicians and global Safety Scientists
- Support to setup the post-marketing safety-related activities such as PMS, Proper Use Guide, local labeling with other local functions and GPS team. Provide input into answers to inquiries from local HCPs.
2) Safety Assessment and Document Review
- Conduct the local assessment of safety information with local safety colleague and support the head of GPS Japan (Safety Controller) to recommend/decide the local safety actions.
- Review safety-related documents such as Research report, Foreign Country Safety Measure Report, Periodic safety reports (Japanese version of Development Safety Update Report (DSUR), Japanese version of Periodic Benefit Risk Evaluation Report (PBRER), other Japan-specific periodic reports) and give advice to the authors
- Support GPS team in preparing response documents when safety inquiries are come from the local HA (PMDA).
3) Provision of Medical Advice and Training
- Give medical comments/advice from physician ‘s perspective to GPS-Japan members at office, meetings.
- Provision of product- or Therapeutic Area-specific safety training to GPS Japan colleagues, and safety training to non- safety colleagues, as required; coach, support and help develop the other GPS staff in Japan on certain medical-scientific aspects
4) Support of Medical/Commercial activities and External Communication
- Where required, represent GPS Japan on Global GPS functional sub teams of assigned programs and give relevant Japanese input into Global Team discussions.
- Represent GPS Japan on safety aspects for the product externally as appropriate, e.g. preparation for and attendance at Japanese regulatory authority meetings, interactions with external advisers or opinion leaders, Safety Advisory Board meeting organized by Medical Affairs in Japan, collaboration with colleagues from partnership companies for co-development or co-marketing etc.
- Review the of local Medical/Commercial materials from safety perspectives and give advises, if applicable.
- Effectively communicate in Japanese regulatory authority inspections in terms of product safety related aspects.