Germany
Global Pharmacovigilance: Medical Assessment, Signal Management, Reference Safety Information Management, Inspections & Audits, PV Quality Management, Safety Variation Management, Medical Writing, Mentorship,Team Building, Business Continuity Plan and Clinical Operations. Preparation, presentation and discussions on global pharmacovigilance processes during health authority inspections and audits. Performing audits as Subject Matter Expert (SME-PV), PV QA - quality management (KPIs, deviation & CAPA management), training, development and opinion sharing on new and existing procedures at the global level. Further, the routine tasks include medical case assessment, literature search, periodic safety reports & risk management plan writing, signal management, Reference Safety Information management... leading to a complete benefit/risk profile management of the products available worldwide. Clinical Safety: Adverse Event handling training at clinical trials sites, Serious Adverse Event assessment, timely reporting to the respective authorities, Review and approval of International scientific marketing material for product promotion and to organize, compile & submit Development Safety Update Reports. Quality Management: Hands on experience at a pharmaceutical compounding & dispensing center to set up Project Management for the quality concerns. Deviation management, CAPA, GMP, KPI and Training. R&D Project Management: API development as well as Formulation development: Involvement from the inception of each project within R&D, including new product identification, Searching Patent status for screening out the projects, Preparation of project timelines/plans and lead indicators for the project, Coordinate with the strategic heads for sourcing, development, regulatory, QA, manufacturing and other teams involved in scheduling and planning, Tracking of Project and Performance Reporting, Completion of projects within the fixed timelines and resources.
Management and reporting of clinical safety data from clinical trials. Preparation and review of safety sections of clinical study protocols. Performing adverse event handling trainings. Development Safety Update Reports (DSUR), signal management. Information Officer, review and approve the international scientific marketing material.