Offer summary

Qualifications:

Doctorate degree or Master's degree with 3 years of experience in biotech/pharmaceutical industry., Bachelor's degree with 5 years of experience in biotech/pharmaceutical industry., Associate's degree with 10 years of experience in biotech/pharmaceutical industry., High school diploma/GED with 12 years of experience in biotech/pharmaceutical industry..

Key responsabilities:

Support Argus system configurations and generate outputs for periodic safety reports.

Ensure delivery of automated safety data outputs and perform quality checks on data outputs.

Participate in collecting business requirements and configuring safety systems for routine outputs.

Contribute to the development of technical solutions and support health authority inspections.

Job description

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

Required profile