Job Description

Fully remote
Standard business hours
Open market rate


Global Safety Manager
*** is seeking a Global Safety Manager to join our Safety Data Analytics (SDA) team.
This group supports pharmacovigilance activities through the maintenance, development and continuous improvement of the global safety system and the provisioning of high-quality data outputs/visualizations.
With limited direction from Safety Data Analyst (SDA) - Sr. Manager, the SDA - Manager may perform the following activities:
• Support Argus system configurations including product, study, license, code lists and reporting rules.
• Generate outputs from the global safety system in support of periodic safety reports (e.g., PADER, PSUR, DSUR) and signal detection outputs.
• Ensure delivery of automated/scheduled safety data outputs.
• Perform Quality Checks/Peer Review as needed on data outputs and system configurations.
• Participate in collecting business requirements for routine safety data outputs.
• Configure safety systems for routine safety data outputs e.g. creation of Advanced Conditions, Development of User Reports
• Participate in user acceptance testing of safety system changes implemented.
• Contribute to the development and maintenance of technical solutions to support safety system and data outputs as required.
• Support Health Authority Inspection and Internal Process Audits within the remit of role and responsibility.

Basic Qualifications
:
Doctorate degree
OR
Master's degree and 3 years of biotech/pharmaceutical experience
OR
Bachelor's degree and 5 years of biotech/pharmaceutical experience
OR
Associate's degree and 10 years of biotech/pharmaceutical experience
Or
High school diploma / GED and 12 years of biotech/pharmaceutical experience


Preferred Qualifications:
Work experience in biotech/pharmaceutical industry
Argus database support work

Job Tags

Work experience placement,

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