PSUR & Medical Writing Specialist

ClinChoice ANZ; Pasig; On-site; PHP 400,000 - 700,000; Full time

Job summary

ClinChoice is seeking a PSUR data coordination specialist to support pharmacovigilance reporting in a fast-paced environment in Pasig, Metro Manila. You will coordinate data for PSURs, liaise with Quality, Medical Operations, Clinical, Regulatory Affairs, and Medical Safety to ensure timely, compliant submissions and data integrity across all PSUR activities.

The role requires strong organizational skills and attention to regulatory requirements, with collaboration across global teams to

Responsibilities

• Responsible for the coordination and compilation of the relevant data to complete a PSUR.
• Ensures open communication with the stakeholders 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 is seeking a PSUR data coordination specialist to support pharmacovigilance reporting in a fast-paced environment in Pasig, Metro Manila. You will coordinate data for PSURs, liaise with Quality, Medical Operations, Clinical, Regulatory Affairs, and Medical Safety to ensure timely, compliant submissions and data integrity across all PSUR activities.

The role requires strong organizational skills and attention to regulatory requirements, with collaboration across global teams to