Accountabilities

As an expert of benefit/risk (B/R) profile, which are assessed by global BR team and aligned among global and local, engage to take safety assurance measures such as preparation of J-RMP, proper use of drugs and closely work with evidence/asset team by providing B/R knowledge and work with global team by inputting local needs/insight.

・Lead to prepare local Risk management Plans in response to Japanese specific requirements (e.g. country-specific format) and content in liaison with GPV functions.
・Implementation and progress of global risk minimization measures, lead to prepare local RMP development and implementation not only for the delegated asset (AT) but also other products as needed. Provide PV input and insights to local labelling documents and educational materials (e.g. SPC, PIL) in time and quality.
・Perform local safety data monitoring not only for the delegated asset (AT) but also other products as needed. Timely information of the respective PVWG Chairperson on any relevant new safety information received from local sources for BI products or for products of the same class. ・Promote implementation of safety assurance measure such as proper use of drug, including preparation of guidelines for them in collaboration with stakeholders (e.g.LRA, legal &compliance) ・-Perform Medical Quality Review of all fatal / life-threatening cases as needed and defines appropriate follow-up measures. Complete ‘fatal case investigation’ report as needed.

Manage health authority requests, potential safety issues and / or crisis management not only for the delegated asset (AT) but also other products as needed and together with global/local stakeholders.

Contribute to the PSPV Culture, Local PSPV Strategy & the establishment and maintenance of a high-quality local PSPV system, review controlled documents (e.g. PV Working Instruction, PV Repository, applicable sections in PSMF annexes, local SOPs, etc.) also contribute to Japan initiatives to promote Patient Safety & Pharmacovigilance concepts and conduct PV trainings, where the training needs were identified, for internal and external customers.

To be ready for inspection and support to management of non-compliance
-Reporting of non-compliances as soon as becomes aware of the issue and contribute to investigate non-compliances and associated CAPA (Corrective and Preventive Actions) activities. Take over CAPA Lead Function, if required. -Establish and support local inspection readiness, participate in PV audits and PV/GPSP/GCP inspections.

Support the implementation activities to enhance PV compliance culture and PV awareness at local level of the organization in line with global recommendations

Proactive cooperation with Global PSPV on any upcoming new regulations or BI processes to assess the local impact and their implementation within the team. -Contribute to setting up/optimizing of local PSPV processes including the takeover of subtasks e.g. creation/revision of the related documentation (Standard Operating Procedures (SOPs), Local PV System Framework, KMed Assets, etc.)

Regulatory and / or Organizational Requirements

Excellent knowledge of applicable global, regional and local PV regulations, BI processes and relevant GxP requirements.
Be compliant and acts within ethics at all times.

Job Complexity

The position requires extensive regulatory, scientific knowledge and balanced risk-based decision making. This needs to take into account needs and requirements of other functions, departments and units.

Interfaces

Local Medical Director, Global Patient Safety & Pharmacovigilance, MSG, CDMAs, LRA, MKT, SL, RWD, GRA, CD&O

Job Expertise

・1+years’ experience in the pharmaceutical industry at MA department
・Experience in the field of clinical development is highly preferable

Job Impact

Conduct and establish internal/external collaborations by sharing best practices

Minimum Education/Degree Requirements

Medical doctor
Experience as a clinician