Job Overview:
The Team Manager of PSS will lead or assist with the management of PSS concerning project allocation and resourcing. This will include general oversight for the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial.
Summary of Responsibilities:
Responsible for the line-management of individuals within team and a project team.
Manage direct reports to ensure staff training records are up to date.
Responsible for managing performance reviews and issues of direct reports.
May manage individuals across multiple teams and will take on responsibility for cross department projects.
Responsibilities will include, but are not limited to, oversight of the following types of tasks:
Entry of safety data onto adverse event tracking systems.
Review of adverse events for completeness, accuracy, and appropriateness for expedited reporting.
Write patient narratives.
Code adverse events accurately using MedDRA.
Clinically significant information missing from initial reports and ensures its collection.




Ensure cases receive appropriate medical review.
Prepare follow-up correspondence consulting with the medical staff accordingly.
Ensure all cases that require expediting reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines.
Reporting of endpoints to clients, regulatory authorities, ethics committees, investigators, and project personnel, if required, within study specified timelines.
General oversight for the management and processing of expedited safety reports (ESRs). This includes, but is not limited to, oversight of the following types of tasks:
Review and update adverse event databases and tracking systems.
Review of adverse events for completeness, accuracy, and appropriateness for ESR.
Review of patient narratives.
Review the coding of adverse events.
Review of reporting of ESRs and endpoints to clients, regulatory authorities, ethics committe

📌 Team Manager (Pune)
🏢 Fortrea
📍 Pune