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Drug Safety Specialist/Non-Line Manager or Staff/Patient Safety and Pharmacovigilance

Company

Boehringer Ingelheim

Location

Shinagawa, Japan

Type

Full-time

**Basic Purpose of Job**

+ Manage case processing activities for Nippon Boehringer Ingelheim’s investigational and marketed products including case submission to Global Patient Safety and Pharmacovigilance (PSPV) and PMDA according to Boehringer Ingelheim (BI)’s internal procedure and local regulation.
+ Conduct safety risk management activities, prepare and submit periodic safety reports and develop and maintain the safety part of local package inserts for the assigned compounds ensuring compliance with BI’s internal procedures and local regulation
+ Contribute to local asset team as an expert of benefit risk of the assigned compounds.

**Accountabilities**

+ Conduct case processing activities and case submission to Global Case Management and PMDA within reporting timelineRelated performance indicators: In time Individual Case Safety Report (ICSR) reporting to GPV/PMDA ≧98%
+ Conduct dissemination of safety information including SUSARs and IND report...

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