Post-Market Surveillance Analyst

COL KCI Colombia SAS; Bogotá ciudad; Hybrid; COP 60,000,000 - 90,000,000; Full time

Job summary

Solventum, una empresa de salud con enfoque en soluciones innovadoras, busca un Analista de Post-Market Surveillance para liderar programas de farmacovigilancia y vigilancia poscomercial. Te encargarás de reportar eventos adversos, gestionar presentaciones ante INVIMA y mantener bases de datos regulatorias.

Requisitos: título en Farmacia u afín, 2–3 años en asuntos regulatorios o farmacovigilancia, dominio de INVIMA y inglés.

Qualifications

• Experiencia en vigilancia poscomercial y farmacovigilancia.
• Conocimientos en asuntos regulatorios y farmacovigilancia.
• Conocimiento de regulaciones INVIMA y normativas de vigilancia postcomercial.

Responsibilities

• Liderar programas de farmacovigilancia y vigilancia postcomercial, reportando eventos adversos y cumpliendo normas locales.
• Gestionar registros de productos, renovaciones y presentaciones regulatorias ante INVIMA.
• Mantener bases de datos regulatorias y evaluar el impacto de nuevas regulaciones.
• Coordinar con equipos regulatorios globales para obtener la documentación requerida.
• Preparar y presentar reportes obligatorios a INVIMA.
• Monitorear la seguridad del producto y apoyar evaluaciones de beneficio-riesgo.
• Promover la concienciación y formación sobre el uso seguro de dispositivos médicos y productos farmacéuticos.

Skills

Post-market surveillance

Regulatory affairs

Pharmacovigilance

INVIMA regulations

English fluency

Education

Bachelor’s degree in Pharmacy or related

Job description

Gracias por tu interés en unirte a Solventum. Solventum es una empresa nueva en el ámbito de salud, pero con una sólida experiencia en la resolución de desafíos que transforman vidas y fortalecen el trabajo de los profesionales de la salud. En Solventum, las personas son el centro de cada innovación que desarrollamos. Con empatía, conocimiento y criterio clínico, trabajamos en conjunto con los líderes más destacados del sector para enfrentar los retos más complejos de nuestros clientes. Mientras continuamos actualizando nuestra Página de Carreras y los materiales dirigidos a los postulantes, es posible que algunos documentos aún muestren la marca anterior. Ten en cuenta que todas las oportunidades laborales publicadas pertenecen a Solventum, y que la Política de Privacidad mencionada https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/a cualquier información personal que proporciones.

Al igual que en 3M, en Solventum se brinda igualdad de oportunidades a todos los candidatos calificados, sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, origen nacional, discapacidad o estatus como veterano protegido.

En Solventum, desarrollamos soluciones innovadoras para enfrentar los retos más complejos de nuestros clientes, liderando avances en salud mediante la combinación de ciencia médica, de materiales y de datos. Nuestro propósito es mejorar la vida de los pacientes y apoyar a los profesionales de la salud para que se desempeñen de la mejor manera posible.

Post-Market Surveillance Analyst

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

• Lead Technovigilance and Pharmacovigilance programs, including adverse event reporting and compliance with local regulations.
• Manage product registrations, renewals, and regulatory submissions with INVIMA.
• Maintain regulatory databases and assess the impact of new regulations.
• Coordinate with global regulatory teams to obtain required documentation.
• Prepare and submit mandatory reports to INVIMA.
• Monitor product safety and support continuous benefit-risk evaluations.
• Promote awareness and training on the safe use of medical devices and pharmaceutical products.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Engineering
• 2-3 years of experience in Regulatory Affairs, Pharmacovigilance, Technovigilance, or Quality.
• Knowledge of Colombian post-market surveillance regulations and INVIMA requirements.
• Experience preparing reports for health authorities is preferred.
• Fluent in English.

Additional qualifications that could help you succeed even further in this role include:

• Strong organizational, communication, and attention-to-detail skills.
• Experience as the Responsible Person registered with INVIMA for Post-Market Surveillance.

Location: Hybrid (Colombia)

Travel: Not required.

Must be legally authorized to work in country of employment without sponsorship for employment visa 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.

Solventum no discriminará a ningún solicitante de empleo por razones de raza, color, edad, religión, sexo, orientación sexual, identidad o expresión de género, origen nacional, discapacidad o estado de veterano.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process.

A new healthcare company with a rich history.

With more than 70 years of delivering healthcare innovations, we continue to move the industry forward by helping to solve our customers’ biggest challenges.

20,000+ employees worldwide.

Solventum relies on the courage and the boundless insights of professionals worldwide to achieve exceptional results for our customers and those who rely on them.

Healthcare that leads with heart and humility starts with listening and never finishes, only evolves.

As long as healthcare challenges remain unsolved, we will be here, united by empathy and a relentless belief that countless lives are improved through our work.

Operations in 38 countries.

Driven by our dedication to improved outcomes for all we serve, we break through by making unprecedented connections that impact lives.

In more than 300 offices and facilities around the world, we work closely with customers and partners to create positive healthcare outcomes that transcend borders.

To realize our shared vision, we harness diverse talents and perspectives from every background to not only address our customers’ most urgent priorities but anticipate the needs of the future.