Senior PV Specialist - LATAM Safety & Compliance

BioSpace; Cundinamarca; Presencial; COP 70.000.000 - 110.000.000; Jornada completa

Descripción de la vacante

AbbVie is pursuing a pharmacovigilance role focused on supporting the Affiliate Safety Representative and the North LATAM cluster, ensuring compliance with regulatory requirements and quality standards across countries.

The position emphasizes liaison with internal teams, vendors and partners to implement PV processes effectively, while acting as ASR backup when designated, with final oversight by the ASR.

Formación

• Minimum 3 to 5 years of pharmacovigilance experience in the pharmaceutical industry.
• Experience in safety-case management, regulatory compliance, and pharmacovigilance audits or inspections.
• Solid knowledge of pharmacovigilance regulations applicable in Latin America and of processes involving ICSRs, PSURs/PBRERs, RMPs, reconciliations, CAPAs and quality systems.
• Experience working with regional or global teams is an advantage.
• Fluent written and spoken English.
• Excellent written and verbal communication, analytical thinking, organisation, planning and follow-up skills; ability to manage multiple priorities in multicultural and regional environments.
• Strong commitment to regulatory compliance, quality, patient safety, integrity, ethics, accountability and continuous improvement.

Responsabilidades

• Pharmacovigilance operations and regulatory reporting
• Quality system, compliance, audits and inspections
• Risk management and regulatory intelligence
• Cross-functional, partner and vendor governance
• Training, regional support and business continuity

Conocimientos

Pharmacovigilance experience

Regulatory compliance

Quality systems

Cross-functional collaboration

Communication skills

Educación

Medical or Pharmacy degree

Descripción del empleo

AbbVie is pursuing a pharmacovigilance role focused on supporting the Affiliate Safety Representative and the North LATAM cluster, ensuring compliance with regulatory requirements and quality standards across countries.

The position emphasizes liaison with internal teams, vendors and partners to implement PV processes effectively, while acting as ASR backup when designated, with final oversight by the ASR.