Pharmacovigilance Senior Specialist

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

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

Support the Affiliate Safety Representative (ASR) and the North LATAM Cluster pharmacovigilance system by executing, coordinating and monitoring pharmacovigilance activities in compliance with AbbVie procedures, applicable local regulatory requirements and established quality standards. Serve as a functional liaison among internal teams, vendors and business partners to ensure effective implementation of pharmacovigilance processes across assigned countries. When formally designated, act as ASR Backup for specified countries or activities in accordance with documented delegations and applicable requirements, while the ASR retains final oversight and accountability.

• 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

Qualifications

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.

• Professional degree in Medicine or Pharmacy.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html