Associate, Medical Writing Pasig City, Philippines

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

Job summary

ClinChoice is seeking a PSUR Coordinator to manage data compilation and reporting with cross-functional teams across Quality, Medical Operations, Regulatory Affairs and Medical Safety.

The role requires coordinating PSUR data collection, ensuring timely submissions, clear communication of delays, and compliance with applicable regulations and internal policies. Based in the Philippines, the position offers exposure to global pharmacovigilance processes.

Responsibilities

• Coordinate and compile data to complete a PSUR.
• Maintain open communication with stakeholders through the PSUR writing process.
• Notify data collection delays to ensure on-time PSUR completion.
• Ensure personal and company compliance with applicable regulations and policies.

Job description

About Clinchoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

About Clinchoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis.

Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally.

We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision.

Job Description

Primary Responsibilities

• Responsible for the coordination and compilation of the relevant 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.