Assistant Workflow Analyst II – Pune
Full-Time | Job ID: 255655
Application Deadline: November 24, 2025
Job Overview
The Assistant Workflow Analyst II will support drug safety and pharmacovigilance operations by managing workflow allocation, case tracking, and critical operational metrics. This role ensures timely and compliant processing of safety cases in alignment with regulatory and organizational standards.
Key Responsibilities
Workflow & Case Management
Review and segregate incoming safety cases based on priority and timelines within the safety database worklist.
Allocate cases to the case processing team according to priority levels and resource availability in consultation with the Team Lead or designated supervisor.
Maintain and update the master case tracking sheet to monitor case progress and workflow status.
Follow up with associates and team leads to ensure timely review, prioritization, and completion of assigned cases.
Tracking, Monitoring & Reconciliation
Perform daily reconciliation of turnaround time (TAT) metrics to ensure all cases are processed in accordance with established SLAs.
Update productivity, quality control, and other operational trackers on a real-time basis; coordinate with Team Leads to ensure data completeness.
Conduct daily reconciliation of received and processed cases to confirm compliance with internal timelines.
Support additional pharmacovigilance activities such as data reconciliation, tracking of operational metrics, and compilation of information from multiple sources.
Minimum Qualifications
BS/BA with 6 months to 2 years of relevant experience, or
MS/MA with 0 to 2 years of relevant experience.
Equivalent experience may be considered in place of formal education.
Relevant experience may include roles in pharmaceuticals, biotechnology, CROs, data management, records management, reporting, workflow management, data monitoring, or data entry.
Experience Required
Strong understanding of the clinical research industry, regulatory requirements, and ICH-GCP guidelines.
Good knowledge of safety databases and safety case workflows.
Awareness of ICSR report types and associated regulatory reporting timelines.
Preferred Qualifications
Bachelor’s degree in a life science or related field with 6 months to 2 years of relevant experience.
Foundational understanding of pharmacovigilance principles.
Knowledge of safety database systems.
MSCIT or similar certification is advantageous.
Proficiency in Microsoft Office applications, with preference for candidates experienced in Excel macros and advanced spreadsheet tools.
Work Environment
The role may be based in an office environment or performed remotely, depending on business requirements.
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