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2024.5.24 [Fri.]

Akihabara UDX 2F AKIBA_SQUARE

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Updated 2024-03-26
Activated 2024-03-26

PV Specialist

Recruiter
Staff Level

This posting is managed by:	Michael Page International Japan K.K./マイケル・ペイジ・インターナショナル・ジャパン株式会社
Company Name	Company is not publicly visible
Job Type	Medical/Pharmaceutical/Bio/Fabric/Food - Clinical R & D
Industry	Pharmaceuticals
Location	Asia Japan Tokyo
Job Description	* PV Specialist position responsible for collection, evaluation, reviewing and reporting adverse event information on marketed and investigational drugs in Japan and overseas to PMDA and Global. Description * Collect, evaluate, review and report adverse event information on marketed and investigational drugs in Japan and overseas to PMDA and Global. * Prepare materials for communicating safety information on the proper use of marketed and investigational medicinal products to the pharmaceutical industry. * Respond to legal and regulatory requirements related to safety work, including periodic safety reports required by the GVP and GCP ministerial ordinances. * Prepare risk management plans and implement them after obtaining the consent of the national regulatory authorities. * Co-ordinate with pharmaceutical companies to which GVP operations are outsourced to ensure that pharmacovigilance operations are carried out appropriately. * Manage and supervise the performance of GVP contractors (CROs). * Understand the requirements of Global PV and overseas regulatory information and carry out pharmacovigilance work. Profile * Experience in safety related work * English language skills - Reading and Writing required, conversational English a plus * Preferred qualification: Pharmacist, Veterinarian, Nurse * University degree in science preferred Job Offer * Great work / life balance * Collaborate with global colleagues in a truly multinational organisation Page Group Japan is acting as an Employment Agency in relation to this vacancy.
Company Info	* Global pharmaceutical company. * Operating across 80 countries to deliver medicines to millions of patients every day, our client offers a uniquely diverse portfolio of products and solutions for patients, with a promising pipeline several core therapeutic areas.
Working Hours	Monday - Friday 09:00 - 17:00
English Level	Business Conversation Level (TOEIC 735-860)
Japanese Level	Fluent(JLPT Level 1 or N1)
Salary	Depends on experience

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