PSUR Writer & Medical Ops Coordinator

ClinChoice ANZ; Pasig; On-site; PHP 600,000 - 900,000; Full time

Job summary

ClinChoice is seeking a PSUR Coordinator to manage data coordination and compilation for periodic safety update reports. You will ensure timely communication with stakeholders across Quality, Medical Operations, Clinical, Regulatory Affairs, and Medical Safety to align on schedules and deliver accurate PSURs.

The role requires meticulous data handling, adherence to regulatory requirements, and proactive problem solving to keep submissions on track and compliant globally.

Responsibilities

• Coordinate and compile data to complete a PSUR.
• Maintain open communication with stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process.
• Flag concerns/delays with data collection/reviews to ensure on-time completion of PSUR reports.
• Ensure personal and Company compliance with applicable regulations, policies, and procedures.

Job description

ClinChoice is seeking a PSUR Coordinator to manage data coordination and compilation for periodic safety update reports. You will ensure timely communication with stakeholders across Quality, Medical Operations, Clinical, Regulatory Affairs, and Medical Safety to align on schedules and deliver accurate PSURs.

The role requires meticulous data handling, adherence to regulatory requirements, and proactive problem solving to keep submissions on track and compliant globally.