Assistant Workflow Analyst II

Job Overview:

The Workflow Analyst will hold the responsibilities of performing drug safety and pharmacovigilance support activities as assigned.

Summary of Responsibilities:

• Segregate cases received as per priority and due dates in the database worklist.
• Assign cases to case processing team based on the priority and availability of resources in consultation with Team Lead or designee.
• Enter data into the Master case tracking sheet. Track and monitor the case progression with help of case tracking sheet. Follow up with associates and/or team leads to ensure timely completion of review and ensure case prioritization.
• Reconciliation of TAT data on a daily basis to ensure all the cases are assigned and reviewed as per SLA.
• Ensure timely updating of productivity, QC and other role specific trackers on a real time basis and follow up with Team Leads for the same.
• Daily reconciliation of received and processed cases to ensure all received cases is processed with internal timelines.
• Perform any other Pharmacovigilance support activities as assigned – tracking various types of information and metrics, reconciliation of data from multiple sources.

Qualifications (Minimum Required):

• BS/BA plus 6 months-2 year of relevant experience.
• MS/MA plus 0 to 2 years of relevant experience.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, working in related areas such as data management, records management, reporting management, workflow management, data monitoring or data entry.

Experience (Minimum Required):

• Good understanding of clinical research industry, regulatory requirements and ICH-GCP guidelines
• Good understanding of safety database
• Good understanding of types of ICSR reports and regulatory timelines for various case types

Preferred Qualifications Include:

• Bachelors in a related science field (preferred) plus 6 months to 2 years of relevant experience.
• Understanding of Pharmacovigilance preferable.
• Good understanding of safety database.
• MSCIT or equivalent certification preferable.
• Technical proficiency with Microsoft Office suite of applications (including hands on experience in Excel Macro programming preferred)

Physical Demands / Work Environment:

• Office environment or remote.

Learn more about our EEO & Accommodations request here.