Analista de Vigilancia Postmercado (Bogotá)

The Impact You’ll Make in this Role

• Putting together dossier and filing requests for new registrations, updating, responding to requests for more information
• Regulatory Management of Imported Pharmaceuticals and Medical Devices
• Analysis of the impact of new regulations on marketed products
• Maintaining regulatory databases
• Communicating with general regulatory teams to obtain relevant documentation for local procedures
• Responsible for the Technovigilance Program for KCI Colombia SAS
• Comply with the Technovigilance Manual and the company’s procedures that define Technovigilance
• Recording, analyzing and managing any adverse event or incident that may be caused by a medical device and biomedical equipment
• Recommending preventive measures to take action immediately after the event occurs
• Guiding the informants in the correct completion of the report form
• Raising awareness among all ...