Checking job availability...
Original
Simplified
It is the spirit of Bayanihan that drives us to continue our legacy of excellence and commitment to care. As an organization, we achieve our successes through good, honest, and persevering hard work - TOGETHER. It is in this way in which our company was built; we progressed as the country's leading Pharmaceutical company, not by sheer luck, but by pure perseverance, integrity, and brotherhood. Grow with us, and be a part of the Bayanihan spirit.
PACKAGING MATERIAL ARTWORK DEVELOPMENT
PACKAGING MATERIAL ARTWORK DEVELOPMENT
- Facilitates development, revision, evaluation and approval of packaging material artworks for new and existing products
- Accomplishes phase-in requirements such as product variation application, change control filing and sell-in kit preparation.
- Participates in alignment meetings with Demand Management Group to set proper timelines/ implementation dates on phasing - in and phasing - out of packaging materials.
- Secures Division’s License To Operate and acts as divisional representative during FDA inspection
- Prepares documents for submission to FDA (in coordination with the Office of Regulatory Affairs) for product registration, renewal and variation applications
- Assists in BE requirements for the initial registration and renewal of product portfolio
- Facilitates local order permit (LOP) application of Dangerous Drugs to PDEA
- With supervision of MD, conducts training programs and exams for new hires or transferees basic medical science, basic pharmacology, pharmacovigilance and product knowledge relative to the division's portfolio
- Attends Continuing Professional Education that is related to the products' portfolio thru internal/ external seminars, workshops and training.
- Ably assist the Medical Director in the review of clinical trials to do the technical preparation and writing of evidence-based tables in support product-related PNF/HTAC (Health Technology Assessment Council) applications (Philippine National Formulary).
- Supports in preparing presentations to Hospital Therapeutic Committees to support marketing and/or operations in the formulary inclusion in these hospitals.
- Assists the Medical Director in planning and coordinating independent quality testing of products if required by hospitals for formulary inclusion.
- Assists the Medical Director in facilitating pharmacovigilance activities such as Adverse Drug Reaction Report investigation, Periodic Safety Updates Report monitoring and Risk Management Plan generation (in coordination with Medical Affairs)
- Handles internal and external product complaints (in coordination with QA)
- Ensures that all enablers are well coordinated with regards to timelines of launching new products and in preparation of sell – in kits prior to products’ phase – in
- Ensures product monographs for MIMS and PPD (Quarterly and Annual Editions) are updated
- Assists Marketing with detailing aids and promotional materials
- Manages records and documentation pertaining to the Medical and Training Department and technical information on the division’s products (Product Folders, BA/ BE reports, etc.
- Provides medical information, replies to product queries from internal and external customers.
- Conducts literature search and provides technical information to support Operations group, PMG, Medical Director/ Consultant and other external requestors.
It is the spirit of Bayanihan that drives us to continue our legacy of excellence and commitment to care. As an organization, we achieve our successes through good, honest, and persevering hard work - TOGETHER. It is in this way in which our company was built; we progressed as the country's leading Pharmaceutical company, not by sheer luck, but by pure perseverance, integrity, and brotherhood. Grow with us, and be a part of the Bayanihan spirit.
PACKAGING MATERIAL ARTWORK DEVELOPMENT
PACKAGING MATERIAL ARTWORK DEVELOPMENT
- Facilitates development, revision, evaluation and approval of packaging material artworks for new and existing products
- Accomplishes phase-in requirements such as product variation application, change control filing and sell-in kit preparation.
- Participates in alignment meetings with Demand Management Group to set proper timelines/ implementation dates on phasing - in and phasing - out of packaging materials.
- Secures Division’s License To Operate and acts as divisional representative during FDA inspection
- Prepares documents for submission to FDA (in coordination with the Office of Regulatory Affairs) for product registration, renewal and variation applications
- Assists in BE requirements for the initial registration and renewal of product portfolio
- Facilitates local order permit (LOP) application of Dangerous Drugs to PDEA
- With supervision of MD, conducts training programs and exams for new hires or transferees basic medical science, basic pharmacology, pharmacovigilance and product knowledge relative to the division's portfolio
- Attends Continuing Professional Education that is related to the products' portfolio thru internal/ external seminars, workshops and training.
- Ably assist the Medical Director in the review of clinical trials to do the technical preparation and writing of evidence-based tables in support product-related PNF/HTAC (Health Technology Assessment Council) applications (Philippine National Formulary).
- Supports in preparing presentations to Hospital Therapeutic Committees to support marketing and/or operations in the formulary inclusion in these hospitals.
- Assists the Medical Director in planning and coordinating independent quality testing of products if required by hospitals for formulary inclusion.
- Assists the Medical Director in facilitating pharmacovigilance activities such as Adverse Drug Reaction Report investigation, Periodic Safety Updates Report monitoring and Risk Management Plan generation (in coordination with Medical Affairs)
- Handles internal and external product complaints (in coordination with QA)
- Ensures that all enablers are well coordinated with regards to timelines of launching new products and in preparation of sell – in kits prior to products’ phase – in
- Ensures product monographs for MIMS and PPD (Quarterly and Annual Editions) are updated
- Assists Marketing with detailing aids and promotional materials
- Manages records and documentation pertaining to the Medical and Training Department and technical information on the division’s products (Product Folders, BA/ BE reports, etc.
- Provides medical information, replies to product queries from internal and external customers.
- Conducts literature search and provides technical information to support Operations group, PMG, Medical Director/ Consultant and other external requestors.