• 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.
• 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, Data Management, Safety, Pharmacy, Law, Technology, Data, Service, Healthcare, Legal