Safety Data Specialist Job

Date: Feb 15, 2019

Location: Beijing, 11, CN

Apply now »
Apply now

Apply for Job

Requisition ID: CLI008278

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 reporting to worldwide regulatory agencies by Global Safety.

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 safety 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 worldwide.
• Participate/perform in training and certification activities for PV GDO.


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

• Provide franchise 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.
• Oversee redistribution of workload within franchise and across franchise with manager support to ensure reporting timelines are met.
• Identify coordinator, team, franchise, training and/or processes related issues and escalate to PV liaison, PV trainer or DMC PV management as appropriate.
• Actively participate and ensure effective communication with different roles in Global 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 MSD 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 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: Safety, Database, Pharmacy, Law, Data Management, Service, Technology, Healthcare, Legal, Data

Apply now »
Apply now

Apply for Job