Post-Market Surveillance & Regulatory Analyst

Solventum; Bogotá; Hybrid; COP 60.000.000 - 120.000.000; Vollzeit

Zusammenfassung

Solventum seeks a Post-Market Surveillance Analyst in Bogotá to lead technovigilance and pharmacovigilance programs, manage regulatory submissions with INVIMA, and monitor product safety.

The ideal candidate holds a Bachelor’s degree in Pharmacy, Chemistry, or Pharmaceutical Engineering, 2–3 years of Regulatory Affairs/Pharmacovigilance experience, and fluent English. Hybrid role in Colombia with global collaboration.

Qualifikationen

• Bachelor’s degree in Pharmacy, Chemistry, or Pharmaceutical Engineering.
• 2–3 years of experience in Regulatory Affairs, Pharmacovigilance, Technovigilance, or Quality.
• Knowledge of Colombian post-market surveillance and INVIMA requirements.
• Fluent in English.

Aufgaben

• Lead technovigilance and pharmacovigilance programs, including adverse event reporting.
• 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 benefit-risk evaluations.
• Promote awareness and training on safe use of medical devices and pharmaceutical products.

Kenntnisse

Regulatory affairs

Pharmacovigilance

Technovigilance

Adverse event reporting

English fluency

Quality management

Ausbildung

Bachelor's degree in Pharmacy, Chemistry, or Pharmaceutical Engineering

Jobbeschreibung

Solventum seeks a Post-Market Surveillance Analyst in Bogotá to lead technovigilance and pharmacovigilance programs, manage regulatory submissions with INVIMA, and monitor product safety.

The ideal candidate holds a Bachelor’s degree in Pharmacy, Chemistry, or Pharmaceutical Engineering, 2–3 years of Regulatory Affairs/Pharmacovigilance experience, and fluent English. Hybrid role in Colombia with global collaboration.