Corporate Pharmacist-Manila

The Corporate Pharmacist isresponsible for gathering, evaluating, organizing, managing, and collating information in a variety of formats, ensuring compliance with regulations set by the government’s regulatory agencies. Maintaining familiarity with company product ranges, planning, undertaking, and regulatory inspections. Must possess at least a Bachelor of Science in Pharmacy A license pharmacist At least three (3) years acute care pharmacy experience Strong understanding of accreditation standards as they relate to medication safety management Written and Verbal Communication Honest, responsible, resourceful, hardworking, and can multi-task & organize work independently. Have a working knowledge of office equipment, materials, supplies, practices, methods, hazards, and safety precautions used and found in and around the work area.Performs storage compliance audit in conformity with FDA and other related agencies. Ensures all documentation related to the renewal of a license or certificate are completed and submitted within the appropriate time frame. b.1 Food and Drug Administration (FDA): b.1.1 License to Operate Permits b.1.2 Certificate of Product Registration b.1.3 Certificate of Exemption b.1.4 Special Certifications b.1.5 Certificate of Product Notification b.2 Philippine Drug Enforcement Agency (PDEA) Licenses b.3 Dangerous Drug Board (DDB) Product Certifications and Exemptions b.4 Electronic Essential Drug Price Monitoring System (EDPMS) Reactivation and Uploading b.5 IPO (Intellectual Property Office of the Philippines) Certificate of Company Logo and Products b.6 GS1 Barcodes Process and files suppliers’ contracts and agreements for both Local and International suppliers. PriortoapplyingforFDAcertificates, the corporate pharmacist must coordinate with the product specialist and purchasing assistant to request required documents from the suppliers. Communicates with international and local suppliers regarding the documents needed for the registration, importation, and distribution of pharmaceutical and medical products. Preparing documentation such as legal/regulatory documents, monitoring/inspection forms for the warehouse, reports and other assigned documentation. Prepares documents and checklists of requirements for product registration with the FDA, DOH, PDEA, and other affiliated government agencies. Conduct audit to ensure compliance to standard operation procedures and workplace safety. Prepares and updates documents for FDA Inspection. Assist in the preparation of conventions and communicate with the coordinator for the registration of PAMET, PSPI, PHAPI, and PHA. Be always present at the time of surprise audits/inspection, meetings, company events and pharmaceutical trainings. Communicates with the National Reference Laboratory and the National Kidney and Transplant Institute for the testing of the samples for product registration and importation. Performs a monthly inventory of pharmaceutical products together with the inventory assistant. Handles the proper disposal of the expired medicines. Prepares orders for the pharmaceutical products. Prepares, files, and monitors documents such as CPR, COE, Special Certifications, CMDN, CMDR, CGMP, ISO, PDEA and LTO licenses, certificates, and agreements. Coordinates with the sales assistant and prepares certifications such as CPR/COE/CMDN/CMDR, CGMP/ISO, and LOA for bidding. Performs EDPMS uploading quarterly and submits PDEA Semi-Annual Report (SAR) every January and July. Updates Controlled Precursors and Essential Chemicals (CPECs) red book weekly or every after purchase together with the inventory assistant. Responsible for the distribution of medicine to employees. Keeping up to date with changes in regulatory legislation and guidelines. Handle escalated complaints diplomatically by investigating and taking the appropriate follow-up actions. Do other related tasks as directed by the Administrative and General Manager. #J-18808-Ljbffr