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 the help of a 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 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 are processed with internal timelines.
- Generate and publish productivity, TAT and quality data reports from the trackers and database, as required.
- Support in generation of metrics and data towards development of presentations for internal/client meetings.
- Perform any other Pharmacovigilance support activities as assigned – tracking various types of information and metrics, ongoing QC of defined process steps and reconciliation of data from multiple sources.
- Analyze data and create reports based on requirements.
- Prepare power point presentations based on the requirement. Review the dashboards and report matrix.
- And all other duties as needed or assigned.
Qualifications (Minimum Required):
- BS/BA plus 3 to 4 years of relevant experience.
- MS/MA plus up 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 databases.
- 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 3 - 4 years of relevant experience.
- Understanding of Pharmacovigilance preferable.
- Good understanding of safety database Argus.
- 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.
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