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 ICSRs 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.