AbbVie · Sydney
OtherFull-timeposted 6d ago
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.
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.
• 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.
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