更新日 2024-03-26
掲載開始日 2024-03-26

PV Specialist

人材紹介
スタッフレベル

この求人の取扱い会社	マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名	会社名非公開
職種	メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種	製薬メーカー
勤務地	アジア日本東京都
仕事内容	* 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.
企業について（社風など）	* 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.
勤務時間	Monday - Friday 09:00 - 17:00
英語能力	ビジネス会話 (TOEIC 735-860)
日本語能力	流暢（日本語能力試験1級又はN1)
年収	経験と能力に基づく