JOB DETAILS

JOB DETAIL

【Main Duty】
・To handle RA, PV and QA tasks as assigned
Regulatory Affairs (RA)
Pharmacovigilance (PV)
Quality Assurance (QA)

【Job Description】
・To handle regulatory activities (e.g. eCTD, GMP clearance, Import license renewal, etc.), life cycle management within good time and in compliance with company policies and local regulations.
・To handle pharmacovigilance (PV) and quality assurance (QA) activities with stakeholders in compliance with local regulations, global and company policies.
・To handle database management.
・To provide recommendations and information related to regulatory, PV and QA to Sales and Marketing, affiliates, etc.
・To establish effective relationship with Thai FDA and gain their trust and respect.

REQUIRED WORK EXPERIENCE

【Must】
・Bachelor Degree
・Female Only
・Age between 30~40 years old
・More than 3 year work experiences as a regulatory affairs officer for drugs with pharmacist license.
・Intermediate Level of English (TOEIC 600 up)
・Must have pharmacist license
・At least basic knowledge of pharmacovigilance
・Can use Microsoft Office(MS office: word, excel, power point, etc.)

【Advantage】
・Drive for results, managing and measuring works, problem solving, customer focus, integrity and trust with positive attitude and active learning.
・Able to work under pressure of dead-line, and a good team player.
・Project management background is preferred.

【Other】
・Other Good EQ, drive for results, problem solving, customer focus, intgrity and trust with positive attitude and active learning.
・Be able to work under presseure, good timeline and project management, good human relationship, self-oriented ・working style while being able to be a good team player.