₱ 35000-45000 PHP / Monthly
Background
Ensuring compliance of establishment / procedures / products to regulatory and pharmacovigilance requirements of FDA
Accountability
Updated regulatory requirements (Licenses, Certificates of Product Registration, permits) and availability of such requirements to enable marketing of products; ensuring pharmacovigilance system
INITIAL PRODUCT REGISTRATION • Review and preparation of dossier, facilitation of submission to FDA, compliance of deficient requirements, monitoring and follow-up of status with FDA and securing approval
RENEWAL OF PRODUCT REGISTRATION OF EXISTING PRODUCTS • Review and preparation of dossier, facilitation of submission to FDA, compliance of deficient requirements, monitoring and follow-up of status with FDA and securing approval
VARIATION APPLICATIONS FOR EXISTING PRODUCTS • Review and preparation of dossier, facilitation of submission to FDA, compliance of deficient requirements, monitoring and follow-up of status with FDA and securing approval
MAINTENANCE OF PHARMACOVIGILANCE SYSTEM • Conduct of PV activities as per schedule/frequency stated in PV /SDEA agreements with principals and as per PFDA guidelines
REGULATORY AND PRODUCTS MonITORING • Prepare and collect documents required for hospital/formulary inclusions of products and bidding requirements• Coordinate with internal and external customers with regards to regulatory requirement
Must-have Qualificationa. Academic requirements – Bachelor’s degree in Pharmacy, Licensed Pharmacist b. Experience – Minimum of 1 - 2 years of work experience in the pharmaceutical industry preferably with background in regulatory affairs. c. Language proficiency – proficiency in written and oral Englishd. Technical Skills – Computer proficiencye. Traits - Interpersonal and management skills; Good communication and negotiation skills; Good working knowledge of regulation of pharmaceuticals (background in ASEAN guidelines in the registration of pharmaceuticals) and pharmacovigilance
Nice-to-have Qualification• Attendance to Qualified Personnel in Regulatory Affairs (QPIRA) Training for Pharmaceuticals and FDA Training on Licensing of Drug Establishments; • Attendance to Pharmacovigilance/Good Vigilance Practice (GVP) trainingWhich departments do the department often contact and coordinate in order to achieve their goals?1) Regulatory Affairs Department of Headquarters- registration requirements, regulatory issues2) Foreign Principals- registration requirements, approval of product labeling materials prior to manufacture of the product, pharmacovigilance requirements (PSUR/ADE reports), product complaints, request for medical or scientific information3) Marketing department - approval and monitoring of promo materials/compliance with regulations on ethical marketing practices/medical information inquiries4) Sales department - pharmacovigilance reporting, product complaints, medical information/technical inquiries on products and requests for documentary requirements for bidding purposes and hospital formulary inclusion applications