Description:
Fully remote
Standard business hours

Global Safety Manager

• We are 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.

Day to Day Responsibilities:    

• 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

Top 3 Must Have Skill Sets:    

• Work experience in biotech/pharmaceutical industry
• MUST have Argus experience
• Ability to query using Oracle SQL
• Prior experience working with GxP validate systems

Soft Skills:

• Strong written and verbal communication skills
• Work independently with minimal supervision (self starter)

Pay Rate market rate on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"