Join our dynamic team where innovation and care converge in a culture that values continuous learning, diversity and transformative career development. Underpinned by THRIVE with Zuellig Pharma, our commitment to transforming the way we grow, care and succeed together as one organization, we are dedicated to helping our people make a meaningful impact in healthcare.
ASSOCIATE, REGULATORY AFFAIRS
Sun Valley, Philippines
Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region.
The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.
- QA
- Responsible in ensuring compliance with Quality Management System to meet quality standards, and support achievement of quality objectives.
- Ensure compliance with the Patient Care and program Standard Operating Procedure.
- Responsible for conducting call quality audit to the Patient Care Consultants
- Perform call quality calibration with the team supervisor and operations manager, trending call quality parameters.
- Responsible for Documentation audit by performing spot checks to evaluate source data comprehensiveness and accuracy
- Responsible in ensuring complete documentation to the system of the Patient Care Consultant by comparing it with the call recording summary
- Ensures compliance with Patient Care and Client Pharmacovigilance procedure
- Ensure that if there is a missed AE to inform immediately the Patient Care Consultant and supervisor/manager for it to be reported within the agreed timeline.
- Attends to internal / external or Client audits.
- Prepares management reports and performs data analysis.
- Conducts regular trainings to Patient Care Consultants and Navigators
- DOCUMENT CONTROLLER
- Responsible for reviewing and routing ISPI documents and forms to the eQMS
- Ensure that the program-specific Standard Operating Procedures are reviewed before due.
- Regularly updating the Masterfile and SharePoint
- REGULATORY AND PROGRAM SUPPORT
- Perform other job functions as may be required from time to time or as may be necessary in support of program objectives.
- Back-up in the absence of Regulatory Affairs Associate
- Reviews the PV SOP and conducts PV training
- Acts as back up in the review and approval of MDRF on updating customer’s LTO
- Keeps abreast of new regulations and industry practices.
Registered Pharmacist
Min. 2+ years of experience in hospital setting or equivalent
Min. 2+ years of experience in Quality Assurance or equivalent