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PV Specialist
* 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.
Client Details
* 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.
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.
Client Details
* 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.
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.
