PV Senior/Specialist

Company Overview
Pharmaceuticals Company

Job Description
research and analysis and reporting on the events, adverse events during the occurrence
- Timely reporting to regulatory authorities (individual cases, various periodic reports)
, timely adverse event reporting to headquarters, detection of safety signals and trend changes
, compliance with industry and internal rules for all medical activities, Thorough maintenance / improvement of compliance with Japanese domestic regulatory requirements and headquarters rules
The following operations are added depending on experience
・ Development of drug risk management plan, monitoring and review of PDCA cycle after formulation
・ Application for deadline of re-examination application items
・ Others, investigation to secure safety including past cases, Analysis, report planning, implementation

Requirements
・ Knowledge of pharmacovigilance (3 years or more, individual case evaluation experience)
・ Pharmaceutical Affairs Law, GVP / GPSP ministerial decree and related work knowledge
・ Basic medicine, pharmaceutical Knowledge
・ Risk management
・ Compliance
・ information gathering, analytical ability
・ English ability (reading and writing required, TOEIC 700 points or more is more acceptable)

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