Safety Data Specialist(JPV) Job

Date: Feb 15, 2019

Location: Beijing, 11, CN

Apply now »
Apply now

Apply for Job

Requisition ID: CLI008285

Under the direction of the Associate Manager/Manager, the Safety Data Specialist is responsible for analyzing, triaging, and processing all adverse experience information received for investigational and marketed products according to standard operating procedures for further reporting to the PMDA by PV of MSD. KK.

In addition, collaborates with staff within the organization as well as cross-functionally.

Qualifications


1. His/Her tasks depend on the Process/role assigned: Registry and Case Processing, Junior PV Lead, Reviewer.

• 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.

2. Skills (include specific skill levels required to apply our Leadership Principles)

• 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
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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

Apply now »
Apply now

Apply for Job