- To complete Product development protocol within the assigned targets
- To conduct comparitve analysis on international competitor products
- To devise and improve packaging of the new and existing products
- To keep ourselves up to date with latest trends in Natural Medicines around the world
- Responsible for conducting clinical trial on Natural Medicinal Product
- Idea generation of new products
- Literature review of research related to our products
- Communication with Regulatory bodies including DRAP, Ethics Review Board
- Development and Recording of Case Report Form
- Handling registration and regulations aspects with Drug Regulatory Authority of Pakistan
- Development of new products From Inception to complete Design and Clinical Evaluation of the same
- Ensuring GMP compliance
- Compiling dossier of each product for registration
- Improvement in site plan and existing documentation
- Development of Packaging components keeping in view current trends and market analysis
- Assist in conduction of Marketing Pre-ficibilities
• Responsible for On time training and reporting of ROCHE delegated tasks and trainings
• Responsible for timely submission of AEs and SAEs and SUSARs
• To conduct Trial according to the Study Protocol with given/assigned Delegated task
• Reviewing, Handling reports of different sites
• Understanding clinical trial protocol and ensuring the same
• Adverse events reporting, informed consents and IRB and related regulatory and ethical protocols
• Responsible for complete site management (site selection, site time lines to site closure)
• Regular updates to study management about site performance by attending teleconferences
• Correspondence with study manager on site related issues
• Complete site file review and documentation
• Responsible to provide all safety information of all clinical trials to the Sponsor and Regulatory authorities