Are you passionate about pharmacovigilance and drug safety? A promising opportunity awaits you! A leading organization is looking for a Safety Science Coordinator I in Pune to join their team and contribute to the critical domain of drug safety monitoring and reporting.

Safety Science Coordinator I

Location: Pune

Time Type: Full time

Summary of Responsibilities:

• Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to:
• Maintenance of adverse event tracking systems.
• Set-up and maintenance of project files, and central files for documentation.
• Assist with the reporting of ESRs and PSRs to clients, Regulatory Authorities, Ethics Committees, investigators and Fortrea project personnel, as required, within study specified timelines.
• Ensure all incoming Adverse Event (AE)/ Serious Adverse Event (SAE) reports are appropriately logged into the departmental tracking application and forwarded to the centralized mailbox.
• Assist with processing of the adverse events, including but not limited to:
• Data entry of safety data onto adverse event tracking systems.
• Write patient narratives and code adverse events accurately using MedDRA (for Marketed products, if applicable).
• Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
• Generate queries for its collection of missing or discrepant information in consultation with medical staff, if needed.
• Submission of expedited SAE reports to clients, Regulatory Authorities, Ethics Committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
• Maintenance of adverse event tracking systems
• Assist with peer/quality review of processed reports and support with trends and actions as needed.
• Assist in the reconciliation of databases, as applicable.
• Assist in the maintenance of files regarding adverse event reporting requirements in all countries.
• Work within the Quality Management System framework, including but not limited to Standard Operating Procedure (SOP), departmental Work Instructions (WIs) etc. as appropriate.
• Prepare and support coordination of safety study files for archiving at completion of projects.
• Arrange and schedule internal and/or external meetings/teleconferences.
• Train and mentor, the PSS Assistants or peers in their day-to-day activities.
• Build and maintain good PSS relationships across functional units.
• Ensure compliance of operations with governing regulatory requirements and applicable study/project specific plans.
• Assume responsibility for quality of data processed. Provide administrative support to PSS personnel.
• All other duties as needed or assigned.

Application Process

Interested candidates are encouraged to apply before March 6, 2025. Don’t miss out on this opportunity to advance your career in the growing field of pharmacovigilance and safety science.

APPLY HERE