Local Safety Manager (Pharmacovigilance)

Roles and Responsibilities:

• Individual Case Safety Report (ICSR) and Reconciliation

Collects, processes and forwards Safety Reports to Global Pharmacovigilance according to relevant global SOPs/WPs, Local SOPs/WPs, and applicable agreements.

• Safety Reporting (Significant/Emerging Safety Issue)

Reports the significant, Emerging Safety Issues to the Health Authority as required according to applicable SOP.

• PV Training

Local PV training material development (including Basic PV training, PV trainings for studies/programs).

• Development and Maintenance of Local PV SOPs/WPs

Prepares, maintains and supervises implementation of current applicable regional and global SOPs/WPs to ensure compliance with regional PV procedures, as needed. The local SOPs/WPs shall also describe and ensure compliance with local regulatory PV requirements which go beyond those covered by applicable regional and global SOPs.

• PV Related Agreement

Preparation, review, update, and maintenance of PV clause in the agreement from PV perspective.

• Aggregate Report

Manages and/or conducts oversight submission and archiving of received Aggregate reports (e.g., Periodic Safety Update Report, Periodic Benefit-Risk Evaluation Report, and/or Development Safety Update Report) if applicable. Submits the Aggregate Reports to the applicable local Health Authorities. Notifies the submission to the responsible local team and Global PV.

• (RMP) Risk Management Plan

Manages and/or conducts oversight of RMP-related PV activities including Risk Minimization Measures.

• Local Literature Search

Identifies Safety Information detected by local literature search based on Otsuka Medicinal Products / Medical Devices, and sends the Safety Information according to relevant SOPs/WPs.

• Study related responsibilities from PV perspective if applicable

Manages promotional materials (e.g., review, approval, etc.) from PV perspective.

• Interface with Other Functions

Safety Information reconciliation with relevant team such as PQC, MI, and social media responsible person.

• Archiving

Ensures that all PV-related documents, including Safety Reports and associated documents and PV-related nominations are retained permanently.

• Regulatory Intelligence

Maintains current knowledge of all local regulatory PV requirements in the territory, communicates with relevant global/regional PV and ensures compliance with them.

• PV Business Continuity Plan (PV BCP)

Development and maintenance of PV BCP in accordance with corresponding GSOP

• Handover Management

Ensure handover management is appropriately conducted and documented per applicable GSOP.

• Others

Manages response to local Health Authority’s PV-related queries/requests according to relevant SOPs/WPs.

Preferred Educational Qualification for the role: Pharmacy

Preferred experience for the role: A minimum of 5 years’ experience in a healthcare environment, or 5 years prior Pharmacovigilance experience or other comparable combination of education.