Chutinun Sorapisetkul
Regulatory Affairs (Pharmacovigilance)
230/80 Soi Ladprao 1, Chomphon, Chatuchak, Bangkok
Summary
Pharmaceutical professional with background in drug safety and regulatory compliance. Skilled in pharmacovigilance, adverse event reporting, and risk management. Known for fostering team collaboration and delivering consistent, high-quality results. Adaptable, reliable, and focused on maintaining patient safety and regulatory standards.
Overview
3
3
years of professional experience
2
2
Languages
Work History
Clinical Research Associate
ICON Clinical Research
09.2023 - Current
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
Clinical Research Associate
Medica Innova
01.2023 - 09.2023
- Monitored patient safety throughout clinical trials and reported any adverse events.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Pharmacist
Lotus Pharmacy
06.2022 - 01.2023
- Educated patients about possible drug interactions and gave special administration instructions.
- Collaborated with pharmacy team members to develop and implement strategies for continuous improvement in quality of care.
- Managed high volume of prescriptions daily while maintaining excellent customer service and attention to detail.
Regulatory Affairs Intern
DKSH (Thailand) Limited
08.2021 - 10.2021
- Updated pharmacovigilance literature research
- Reported adverse event to HPVC form
- Checked product quality complaint associated with adverse event and special situation
- Reviewed and checked on leaflet (Thai and English version) and packaging of drug product
- Updated and monitored law and announcement about medicines, healthcare products and medical devices
- Reviewed advertisement documents associating with application form
Education
Bachelor of Pharmaceutical Sciences - Social And Administrative Pharmacy Major
Chulalongkorn University
Bangkok, Thailand 04.2001 -
Skills
Project management
Patient safety
Problem-solving abilities
Adaptability and flexibility
Attention to detail
IRB submissions
Quality control
Relationship building
Time management
Team collaboration
Timeline
Clinical Research Associate
ICON Clinical Research
09.2023 - Current
Clinical Research Associate
Medica Innova
01.2023 - 09.2023
Pharmacist
Lotus Pharmacy
06.2022 - 01.2023
Regulatory Affairs Intern
DKSH (Thailand) Limited
08.2021 - 10.2021
Bachelor of Pharmaceutical Sciences - Social And Administrative Pharmacy Major
Chulalongkorn University
04.2001 -
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