Savvy, Inc.
Global Safety Mgr Dale WorkForce Solutions Thousand Oaks, CA Inte...
Savvy, Inc. - Thousand Oaks, California, United States, 91362
Work at Savvy, Inc.
Overview
- View job
Overview
Client: Biotech industry
Job: Global Safety Manager
Location: 100% remote from US
Duration: 1 year contract, open to extensions
Client 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.
Responsibilities
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 Skills
Management And Manufacturing Pharmaceutical Manufacturing
#J-18808-Ljbffr
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 Skills
Management And Manufacturing Pharmaceutical Manufacturing
#J-18808-Ljbffr