Regulatory Affairs (PV)

General responsibilities :

• Product Vigilance Management
• Receive and review individual case safety report (ICSRs) for accuracy and completeness and proceed as per client’ requirement and local regulation.
• Follow up with reporter for clarification and completion when necessary
• Cooperate with QA department and MA department for suspected adverse events related to quality defect and medical inquiry.
• Report ICSR and safety information to clients and health authority.
• Create projects to support RA and PV works and /or manage special projects well with others
• PV team is as nominated person as per SD-RGA-RA-29.
• Roles and responsibilities of pharmacovigilance activities or tasks cover on behalf of clients as agreed with clients requirement/ PV agreement.
• Train relevant persons regarding safety information, pharmacovigilance, medical device vigilance and other healthcare products.
• Monitor medical and scientific literature for published articles relevant to safety profile for assigned product(s)
• Manage pharmacovigilance, medical device vigilance and other healthcare products database.
• Manage relevant aspects of safety agreement with clients.
• Manage and ensure compliance of safety reporting in according with standard procedures, safety agreement and local regulations.
• Support manager to develop SOP /SD /WI for vigilance management.

Job requirements :

• Bachelor’s Degree in Pharmacy or Science or related health product field
• Attention to detail and ability to overview a task
• International and local guideline regarding safety regulation for healthcare products
• Documentation management

• Life insurance
• Provident Fund
• ค่าทันตกรรม 5,000 บาท/ปี
• ตรวจสุขภาพประจำปี, ประกันสุขภาพกลุ่ม
• 5-day work week
• Social security
• Health insurance
• ประกันสุขภาพกลุ่ม OPD , IPD ตามแผนที่กำหนด
• Accident Insurance
• สิทธิการลาพักร้อน 13 วัน/ปี
• Annual bonus