**3M Health Care is now Solventum** **At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.** **We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.** **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 global 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 users and potential reporters of your organization in the Technovigilance Program, the security and proper use of medical devices. - Preparing, analyzing, and immediately submitting to the National Institute of Drug and Food Surveillance (Invima) any report of a serious adverse event or incident. - Preparing, analyzing and submitting periodic reports to the National Institute of Drug and Food Surveillance (Invima) on non-serious adverse events or incidents. - Taking the mandatory training by INVIMA to be responsible for the Technovigilance program, registered with the authority. - Responsible for the Pharmacovigilance Program for KCI Colombia SAS - Complying with the Pharmacovigilance Manual and the company's procedures that define Technovigilance. - Specific dedication and availability to develop the activities of the company's Pharmacovigilance program. - Preparing, analyzing, and presenting the report of both serious and non-serious and expected and unexpected adverse events, as well as therapeutic failures. The periodicity of such reports must be aligned with the regulation. - Preparing, analyzing and presenting the report without events, reports based on literature and health alerts issued by other world agencies. The periodicity of such reports must be aligned with the regulation. - Preparing, analyzing and presenting the safety report. The periodicity of such reports must be aligned with the regulation. - Taking the mandatory training by INVIMA to be responsible for the Pharmacovigilance program, registered with the authority. - Continuously evaluate the benefit-risk ratio of the company's pharmaceutical products, to find areas for improvement in the technical information of the products. - **Qualifications**: - Preferred knowledge and experience in Quality and Regulatory Affairs. - Solid knowledge in the Colombian Post Market Surveillance Standards either for Medical Devices and Pharmaceutical Products. - Preferred experience in elaborating reports to Health Authorities. - Proficient in Spanish and English. - Excellent attention to detail, time management, and organizational skills. - Strong interpersonal and communication skills. - Strong desire to work with others and create long lasting cooperative relationships. - **Nice to Have**: - Previous experience as Responsible Person registered at INVIMA for Post market Surveillance. **Your Skills and Expertise** - Completed Bachelor education in Chemistry, Pharmacist, Pharmaceutical Engineering, Biomedical Engineering is required. - Continuing education or courses in Post market Surveillance and International Standards for Postmarket Surveillance is an asset. Additional qualifications that could help you succeed even further in this role include: - none **Work location**: - **Hybrid** **Travel: No travel required** **Relocation Assistance: Not authorized** **Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).** **Supporting Your Well-being** Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Solventum es un empleador que ofrece las mismas oportunidades. 3M no disc