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Safety Data Specialist(JPV) Job - China  

MSD (company)


Posted on : 30 May 2017

Project Description

Safety Data Specialist(JPV)-CLI005961

Description

" Perform registry and case assignment tasks as needed.
" Perform data entry/review of all adverse experience information received and processed within internal database within the established timeframes.
" Through daily case prioritization activities, reports are completed within the established timeframes to ensure compliance with internal, business partner, and regulatory agency reporting requirements.
" Participate/perform in training and certification activities for JPV.

Other activities that the Safety Data Specilaist can assume depending of the role:

" Provide team support by ensuring the appropriate resources such as SOPs and product/protocol guidelines are available and routinely updated to ensure the quality of reports.
" Identify coordinator, team, training and/or processes related issues and escalate to JPV liaison, JPV trainer or DMC JPV management as appropriate.
" Actively participate and ensure effective communication with different roles in Japan PV Safety, DMCs and other areas.
" Perform case review of adverse experience information within the established timeframes to be compliant with internal, business partner, and regulatory agency reporting requirements worldwide.
" Assist managers with reviewing individual coordinator report quality.

Qualifications

" A bachelor's degree, preferably in a medicine, pharmacy, nursing or biological science
" Excellent organizational, workload prioritization and time management skills
" Excellent overall communication skills with advanced oral and written Japanese skills
" Excellent overall communication skills with advanced written English skills
" Advanced computer skills
" Independent, strong analytical and problem solving skills
" Good sense and awareness of regulations and policies
" Able to work under the pressure, strong sense of responsibility and accountability

Job: Clinical Data Management Job Title:Assoc. Spclst, Clinical Data Mgmt

Primary Location: APAC-CN-11-Chaoyang

Employee Status: Regular

Number of Openings: 1

Company Trade Name:MSD


Job Segment: Database, Safety, Law, Pharmacy, Compliance, Technology, Service, Legal, Healthcare


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