Associate, Japan Pharmacovigilance


Job Description

9.4 billion spend on Research and Development. That commitment resulted in 24 major regulatory approvals in 2019 in the US, EU, Japan and China.

Major Accountabilities:
1. Join cross-functional teams as PVO representative and resnponsible for safety matters relating to investigational and marketed drugs.
2. Conduct training and provide mentoring of Patient Safety junior Associates and other line functions/business units and vendors (e.g. Clinical Development, RA, Sales, Medical, GCO, etc).
3. Answer product related safety inquiries *(using approved information from the Japan Package Insert) to better educate HCP and enable them to make informed decisions regarding treatment for their patients
4. Contribute to all required Japan regulatory periodic reports, re-examination dossier.
5. Support Global Medical Safety in monitoring the safety profile of product by raising attention to any potential issues or signals. Lead working groups when a safety issue occurs for investigation and assessment of the specific problem(s) and for the proposal and implementation of any action/change recommended and approved without undue delay
6. Provide support as required for, regulatory authority inspections and audits.
7. Update of J-RMP
8. Work with RA/PI to prepare for PVO’s responsible parts of labelling change
9. Draft safety parts of J-CTD dossier including J-RMP
10. Prepare and conduct EPPV
11. Ensure adequate reporting of foreign safety measure report/research report in accordance with company procedures
12. 100% timely delivery of all training requirements including compliance

Minimum Requirements

Global Drug Development
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Associate, Japan Pharmacovigilance

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