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PSUR Writer at ClinChoice
, , Philippines -
Full Time

Start Date

Immediate

Expiry Date

28 Dec, 25

Salary

0.0

Posted On

29 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Coordination, Data Compilation, Communication, Regulatory Compliance, Medical Operations, Clinical Operations, Pharmacovigilance, Quality Assurance

Industry

Pharmaceutical Manufacturing

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. 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.
Responsibilities
The PSUR Writer is responsible for coordinating and compiling relevant data to complete a PSUR. They ensure open communication with stakeholders throughout the writing process to adhere to schedules and address any concerns or delays.