Pharmacovigilance Senior Specialist

Allergan; Bogotá; Presencial; COP 60.000.000 - 110.000.000; Jornada completa

Descripción de la vacante

AbbVie seeks a Pharmacovigilance professional to support the North LATAM Cluster, coordinating PV activities across countries in compliance with AbbVie procedures and local regulations.

You will act as a liaison among internal teams, vendors and partners to ensure safe data handling, timely reporting, and robust governance of pharmacovigilance programs.

Minimum 3–5 years PV experience, a Medical or Pharmacy degree, fluent English, and proven ability to work across multicultural regional teams.

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 ICSR, PSURs/PBRERs, RMPs, reconciliations, CAPAs and quality systems.
• Experience working with regional or global teams is an advantage.
• Fluent written and spoken English.

Responsabilidades

• Support the maintenance and implementation of local pharmacovigilance processes, procedures, systems and documentation.
• Oversee the receipt, processing, follow-up, reconciliation and reporting of adverse events and other safety information; monitor applicable timelines for ICSR and other regulatory reports; and support aggregate reports, PSURs/PBRERs, RMPs and local requirements, as applicable.
• Coordinate follow-up of deviations, observations, CAPAs, change controls and exceptions; maintain training and compliance records; participate in regulatory inspections and audits; and organise evidence and remediation documentation.
• Monitor relevant pharmacovigilance regulatory changes, contribute to impact assessments and gap analyses, and update local procedures, regulatory matrices and tracking documentation.
• Act as a pharmacovigilance contact for internal functions and assess initiatives that may generate safety information; support PV agreements and SDEAs; monitor vendors against contractual obligations and collaborate with regional and global teams.

Conocimientos

Fluent English

Analytical thinking

Communication skills

Educación

Medical or Pharmacy degree

Descripción del empleo

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

1. Pharmacovigilance operations and regulatory reporting

Support the maintenance and implementation of local pharmacovigilance processes, procedures, systems and documentation. Oversee the receipt, processing, follow-up, reconciliation and reporting of adverse events and other safety information; monitor applicable timelines for IC SRS and other regulatory reports; and support aggregate reports, PSURs/PBRERs, RMPs and local requirements, as applicable.

2. Quality system, compliance, audits and inspections

Support the pharmacovigilance quality system across North LATAM Cluster countries. Coordinate follow-up of deviations, observations, CAPAs, change controls and exceptions; maintain training and compliance records; participate in regulatory inspections and internal or third-party audits; and organise evidence and remediation documentation through closure.

3. Risk management and regulatory intelligence

Monitor relevant pharmacovigilance regulatory changes, contribute to impact assessments and gap analyses, and update local procedures, regulatory matrices and tracking documentation. Maintain awareness of product benefit-risk profiles and support local implementation of RMPs, additional risk-minimisation measures, safety communications, trend reviews and related investigations when required.

4. Cross-functional, partner and vendor governance

Act as a pharmacovigilance contact for relevant internal functions and assess initiatives that may generate safety information. Support implementation and oversight of pharmacovigilance agreements and Safety Data Exchange Agreements (SDEAs). Monitor vendors, distributors and business partners against applicable contractual pharmacovigilance obligations and collaborate with regional and global teams on new processes, tools and requirements.

5. Training, regional support and business continuity

Coordinate and deliver pharmacovigilance training for employees and vendors, maintain local training materials, monitor completion and promote a strong reporting culture. Support regional compliance, quality, inspection and continuous-improvement projects. Participate in business-continuity, disaster-recovery and contingency activities for critical pharmacovigilance operations, escalating critical matters promptly to the ASR.

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 IC SRS, 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, visit https://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