PSUR Writing Associate – Medical Data Coordinator

clinchoice; Pasig; On-site; PHP 600,000 - 1,200,000; Full time

Job summary

ClinChoice in the Philippines is seeking a PSUR coordinator to support data collection and compilation for ongoing safety reports. You will collaborate with Quality, Medical Operations, Clinical, Regulatory Affairs, and Medical Safety to align on schedules and deliver accurate PSURs on time.

The role requires clear communication, attention to regulatory requirements, and a proactive approach to identify and address delays.

Qualifications

• PSUR data coordination and compilation.
• Liaise with Quality, Medical Operations, Clinical, Regulatory Affairs, Medical Safety.
• Ensure adherence to PSUR schedules and timelines.
• Maintain compliance with Federal, State, local and Company regulations.

Responsibilities

• Coordinate and compile data to complete a PSUR.
• Maintain open communication with stakeholders through the PSUR writing process.
• Flag concerns or delays in data collection to ensure on-time PSUR delivery.
• Ensure personal and company compliance with all applicable regulations.

Job description

ClinChoice in the Philippines is seeking a PSUR coordinator to support data collection and compilation for ongoing safety reports. You will collaborate with Quality, Medical Operations, Clinical, Regulatory Affairs, and Medical Safety to align on schedules and deliver accurate PSURs on time.

The role requires clear communication, attention to regulatory requirements, and a proactive approach to identify and address delays.