Safety Operations Role - Global Business Solutions/Patient Safety & Solutions

Safety Operations Role

The purpose of the Safety Operations - Global Business Solutions, Global Patient Safety & Solutions, is to provide operational support to enable all of pharmacovigilance and observational study activities in Japan in accordance with Japan regulations and rules, such as Pharmaceutical and Medical Device Law, Good Vigilance Practice (GVP), Good Post-Marketing Study Practice (GPSP), etc.

Job Responsibilities :

- Safety management activities related to investigational products and devices during development phase

- DSUR development, RMP development, Post launch RMP materials development, Query responses, etc.

- Safety management activities related to products and medical devices in the post-launch phase

- RMP maintenance, Safety material development and maintenance, Safety report development, Safety Core Capability activities

- Support to Safety Manager (An-Seki), EPPV management, Safety information provision (Den-Tatsu), etc.

Clinical Case Management :

- Operational support for all of case management activities (e.g. case receipt, metrics, etc.) in development and post launch phase

- System support (e.g. u-Guides, LSS, I-Kiki, etc.)

Evidence Creation :

- Operational support for PMSS and observational studies (e.g. protocol development support, study team meeting support, GPSP inspection support, etc.)

Qualification:

- Completion of required training, such as Red Book, understanding of procedures, operation manuals, etc.

- Microsoft applications basic level skill (Word, Excel, PowerPoint, Teams, etc.)

- Good verbal (conversational level) and written communication in Japanese

- Ability to use computer systems (e.g. LSS, RIM, PostMaWatch, Vigilia, Veeva MedCom, QualityDocs, etc.)

- Work experiences in pharmaceutical companies, especially areas in pharmacovigilance and observational study.