QR Associate
Ho Chi Minh City
Reported to: QRVI Manager
Job descriptions:
• Responsible for registration document preparation by contacting relevant internals to ensure timely & quality submission of applications and regulatory compliance of Vietnam & Cambodia portfolio to MOH to sustain continuous market supply and patient safety.
• Provide excellent expertise and knowledge of regulatory environment as well as contact to MOH to support promotion company products in Vietnam & Cambodia
• Support Marketing/Sales Teams on tender list and support inclusion of PF’s product in national formulary listing.
• Regulatory assessment of new business opportunity local implementation
• Ensure that updates or new regulatory requirements are reflected in Require Base or other information sources so that these are addressed
• Responsible for document preparation to list the company’s products in innovators list, ICH/PICs GMP list
• Responsible for promotional materials document preparation and submission to Vietnam MOH.
• Ensure compliance to quality of local RA organization by ensuring a proper Quality system, tacking log.
• Responsible for pharmacovigilance related activities: PV report to Head Quarter and local MOH aligning with relevant Head Quarter and MOH legislation.
• Monthly QRV report to QRVI Manager.
Education and experiment requirements:
• Bachelor degree in Pharmaceutics, at least 2 years experience is preferred
• Required capabilities (skills, experiences, competencies)
• Knowledge of relevant regulations in Vietnam and Cambodia
• Experiences in pharmaceutical industry
• Team work spirit
• Sense of Urgency and Account of Responsibility
• Proficiency in English
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Company Size:
Industry:
Pharmaceutical
Job Category:
Other
Job Type:
Location:
Ho Chi Minh City
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