Pharmacovigilance Senior Specialist

Location: Bogota, Cundinamarca, Colombia

Company

hirify.global develops medicines and healthcare solutions across immunology, oncology, neuroscience, and aesthetics.

What you will do

• Support the Affiliate Safety Representative and the North LATAM Cluster pharmacovigilance system.
• Process, follow up, reconcile, and report adverse events and other safety information.
• Monitor timelines for ICSRs and support PSURs/PBRERs, RMPs, and other regulatory reports.
• Coordinate deviations, CAPAs, change controls, audits, inspections, and remediation activities.
• Monitor regulatory changes, support risk-management measures, and maintain local procedures and tracking documentation.
• Coordinate pharmacovigilance training and oversee vendors, distributors, business partners, and safety data exchange agreements.

Requirements

• 3–5 years of pharmacovigilance experience in the pharmaceutical industry.
• Experience with safety-case management, regulatory compliance, audits, or inspections.
• Knowledge of Latin American pharmacovigilance regulations, ICSRs, PSURs/PBRERs, RMPs, reconciliations, CAPAs, and quality systems.
• Fluent written and spoken English.
• Professional degree in Medicine or Pharmacy.
• Strong communication, analytical, organisational, planning, and follow-up skills in multicultural environments.

Culture & Benefits

• Work focused on regulatory compliance, quality, patient safety, integrity, ethics, and continuous improvement.
• Collaboration with regional and global teams, internal functions, vendors, distributors, and business partners.
• Participation in business-continuity, disaster-recovery, and contingency activities for critical operations.
• Equal opportunity employment and a commitment to integrity, innovation, and community service.