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- Qualified as physician
- Working experience as a physician at hospitals/clinics in Japan
- Working experience in pharmaceutical companies would be preferable.
- Create safety related documents for CTD, including Japanese version of Risk Management Plan
- Attend consultation meetings in development phase, including preparation for submissions.
- Review safety parts in documents, such as Individual Safety Case Report, various kinds of periodic safety reports submitted to PMDA.
- Discuss safety matter with Global physicians in HQ in Germany
- Fluent in English as well as Japanese
SPECIFIC JOB DESCRIPTION
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.
Major financial impact: Lack of appropriate medical safety strategy for products may have significant negative implications on drug development programs and/or marketing authorizations.
- Provide understanding of medical-scientific aspects to accelerate creation of safety aspects for submissions in Japan
- Strategies improvements on the safe use of medicinal products in development and post marketing with focus on the Japanese environment
- Act as the point of contact for local support of clinical programs.
SCOPE OF PEOPLE RESPONSIBILITY
Interfaces with other Departments/Functions:
- Internal GPSI groups and GPS PV groups (i.e. GPS PVSO, GPS LCM, GPS Operations, GPS Regions, EU QPPV)
- local GED/TIPs, local CDC; local Medical Affairs, local RA, local BE&MW, GCO, RCO, CoE CS, Medical Excellence and Communication, Corporate Communication, GPU, Business Units, Regulatory Affairs
- Global/local Product/Program Teams, Clinical Development Teams, Submission Teams
- Regulatory Agencies, Consulting experts, members of SMCs/DSMBs and co-development/business partners as appropriate
- Must be prepared to describe and demonstrate these job attributes to regulatory authority inspectors during pharmacovigilance or other regulatory authority inspections
Required professional experience and necessary training
- Physician with broad clinical experience
- Fluent in written and spoken English
Necessary professional experience
- Several years of medical experience as a physician, preferably working in the therapeutic area of oncology, immunology or internal medicine.
- Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety decision-making based on clinical acumen and medical judgment)
- Excellent knowledge of product development process and experience of cross-functional team work.
- Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
- good medical understanding of the relevant therapeutic area(s)
- Professional experience in an international environment
JOB-SPECIFIC COMPETENCIES & SKILLS
Specifies personal skills and competencies required
- Enthusiastic about promoting patient’s well-being through working in drug safety area.
- Excellent medical judgment in safety decision-making
- Strong, mature project leadership and influencing skills
- Entrepreneurial thinking and striving to move project(s) forward, within budget and timelines
- Strong team player and excellent networking skills
- Proven ability to chair meetings effectively
- Solution and results orientated
- Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets
- Excellent verbal and written communication skills (in English language)
Recruiting contact: Fang Liu
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