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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs and Pharmacovigilance, with a strong focus on compliance with INVIMA regulations and post-market surveillance. Capable of managing product registrations and preparing mandatory reports while promoting safe use of medical devices and pharmaceuticals.
Highest-signal resume keywords
Regulatory Affairs ExperiencePharmacovigilance KnowledgeINVIMA CompliancePost-Market SurveillanceReport Preparation for Health Authorities
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Adverse Event ReportingRegulatory SubmissionsRegulatory Database ManagementBenefit-Risk EvaluationProduct RegistrationPharmaceutical EngineeringQuality Management
Soft Skills
Strong Organizational SkillsCommunication SkillsAttention to Detail
Industry Keywords
Colombian Post-Market Surveillance RegulationsTechnovigilancePharmacovigilanceHealth AuthoritiesResponsible Person for INVIMA
About the role
Key responsibilities & impact- 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
- Travel is not required
Requirements
What you’ll need- 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 regulations and INVIMA requirements
- Experience preparing reports for health authorities is preferred
- Fluent in English
- Strong organizational, communication, and attention-to-detail skills
- Experience as the Responsible Person registered with INVIMA for Post-Market Surveillance
- Must be legally authorized to work in Colombia without sponsorship for employment visa status
Benefits
Comp & perks- Competitive pay and benefits
- Programs supporting physical and financial well-being
- Hybrid work arrangement
- Equal opportunity employment
