Checking and approving product specifications and labeling
maintenance e.g., Renewals Pharmacovigilance e.g., LRMP Labelling and Artwork Management Robust Health Authority updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments within agreed timelines. Labelling & Artwork Management: Ensure labelling and artworks are effectively effectively managed through the company, Global Labelling Business Process. Co-ordinate the operations of Gazelle non-submission of critical variations Product labelling activities successfully completed within specified
maintenance e.g., Renewals Pharmacovigilance e.g., LRMP Labelling and Artwork Management Robust Health Authority updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments within agreed timelines. Labelling & Artwork Management: Ensure labelling and artworks are effectively effectively managed through the company, Global Labelling Business Process. Co-ordinate the operations of Gazelle non-submission of critical variations Product labelling activities successfully completed within specified
maintenance e.g., Renewals Pharmacovigilance e.g., LRMP Labelling and Artwork Management Robust Health Authority updates, new indications, technical changes to the label or the packs, PBRERs, and post approval commitments within agreed timelines. Labelling & Artwork Management: Ensure labelling and artworks are effectively effectively managed through the Company. Global Labelling Business Process using the GAZELLE system. Co-ordinate non-submission of critical variations Product labelling activities successfully completed within specified
Downtime & Warranty. Develop SPIS, SPPS & LABEL for P&A (Service parts) Liaise with external
dispensing areas, including proper storage and labeling of materials Perform routine maintenance and calibration
Signalling Meeting, Drug Safety Committee, and Labelling Committee – and providing medical input for benefit/risk safety signal evaluations, updates to product labeling documents, responses to regulatory agency inquiries
Signalling Meeting, Drug Safety Committee, and Labelling Committee – and providing medical input for benefit/risk safety signal evaluations, updates to product labeling documents, responses to regulatory agency inquiries
Oversee special market sampling, accuracy of labelling and administration. Managing the quality and quantity
regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc. Update and maintain