PSUR & Regulatory Medical Writing Associate

ClinChoice; Pasig; On-site; PHP 700,000 - 1,000,000; Full time

Job summary

ClinChoice in the Philippines is seeking a PSUR Coordinator to support pharmacovigilance activities and ensure timely PSUR submissions.

You will coordinate data collection, liaise with Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, and other stakeholders, and maintain compliance with applicable regulations.

The role emphasizes timely communication, data accuracy, and adherence to schedules across global teams. This position is based in the Metro Manila area.

Responsibilities

• Coordinate and compile data to complete a PSUR.
• Ensures open communication with the stakeholders (Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, etc.) through the PSUR writing process to ensure adherence to published schedules.
• Communicate concerns/delays with data collection and/or reviews within the PSUR Manager Medical Operations to ensure on time completion of the PSUR reports.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Job description

ClinChoice in the Philippines is seeking a PSUR Coordinator to support pharmacovigilance activities and ensure timely PSUR submissions.

You will coordinate data collection, liaise with Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety, and other stakeholders, and maintain compliance with applicable regulations.

The role emphasizes timely communication, data accuracy, and adherence to schedules across global teams. This position is based in the Metro Manila area.