Company DescriptionAbout 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 DescriptionJob Summary
The Pharmacovigilance Specialist supports the Affiliate Safety Representative and Regional Pharmacovigilance Lead in coordinating and executing affiliate pharmacovigilance activities in Saudi Arabia. The role helps ensure that AbbVie meets its legal, regulatory, quality and ethical responsibilities for patient safety and maintains an effective local pharmacovigilance system.
The role serves as Back-up Affiliate Safety Representative and Saudi Arabia National Qualified Person for Pharmacovigilance Deputy. The incumbent maintains continuous readiness to act for the National QPPV and assumes delegated or back-up responsibilities when required. The role has sufficient access, authority and escalation channels to influence the performance of the pharmacovigilance quality system, support compliance with Saudi Good Pharmacovigilance Practice requirements and act as a pharmacovigilance contact for the Saudi health authority and AbbVie Global Patient Safety.
Primary AccountabilitiesNational QPPV Deputy and Regulatory Accountability
Maintain the knowledge, training, access and availability required to fulfil the National QPPV Deputy role in accordance with Saudi regulations, AbbVie procedures and the approved country attestation or delegation documentation.
Act for the National QPPV when formally delegated or when back-up coverage is activated, and support the National QPPV in maintaining oversight of the local pharmacovigilance system at all other times.
Serve, as required, as a single local pharmacovigilance contact point for the Saudi health authority on a 24-hour basis and as a contact point for pharmacovigilance inspections.
Remain permanently and continuously reachable in line with applicable local requirements, approved back-up arrangements and the affiliate business continuity plan.
Maintain sufficient authority to influence the pharmacovigilance quality system and to promote, maintain and improve compliance with applicable legal and regulatory requirements.
Ensure that delegated National QPPV activities, back-up arrangements and access to relevant medical expertise are clearly documented and kept current.
Provide full and prompt responses to health authority requests for information required to evaluate the benefit-risk profile of a medicinal product.
Provide input into regulatory actions arising from emerging safety concerns, including urgent safety restrictions and communications to healthcare professionals or patients, as applicable.
Oversight of the Pharmacovigilance System
Support oversight of the performance and functioning of the local pharmacovigilance system, including its quality system, procedures, contractual arrangements, databases, compliance data, audit outcomes and training requirements.
Maintain access to the Pharmacovigilance System Master File and relevant national pharmacovigilance system files, and support confirmation that information relating to Saudi Arabia is accurate, complete and current.
Review local pharmacovigilance activity metrics and compliance indicators. Identify risks, escalate issues promptly and track agreed actions to completion.
Maintain awareness of the validation status and significant changes to relevant safety databases, including failures identified during validation and the corrective actions taken, where applicable.
Collaborate with Regional Pharmacovigilance teams to provide the metrics, records and supporting information needed by the Affiliate Safety Representative and National QPPV to demonstrate system oversight.
Monitor the effectiveness of local interfaces with Medical Affairs, Regulatory Affairs, Clinical, Quality, Commercial, Customer Service and other functions that may receive or generate safety information.
Quality Management System and Procedures
Develop, implement and maintain local pharmacovigilance procedures in line with AbbVie corporate procedures, Saudi regulatory requirements and the local operating model.
Ensure that local procedures adequately address back-up and delegation, training, local individual case safety reports, medical assessment support, seriousness and causality assessment, local literature screening, national pharmacovigilance system files, risk minimization measures, signal management, safety variations and periodic or aggregate reporting, as applicable.
Manage non-conformities and planned departures from corporate or local pharmacovigilance procedures through the applicable global issue and exception management process.
Support the development, implementation and timely completion of corrective and preventive actions.
Maintain controlled records that demonstrate compliance with local requirements and AbbVie procedures.
Adverse Events and Safety Reporting
Support processes for the intake, processing, translation, follow-up, medical assessment support and reconciliation of adverse events and other safety information from spontaneous reports, solicited programs, clinical studies, product complaints and other reportable sources.
Partner with Regional Pharmacovigilance teams to ensure timely submission of clinical and post-marketing individual case safety reports to the Saudi health authority, ethics committees and investigators, as required.
Support the production, review and submission of periodic and aggregate safety reports, including periodic safety update reports, periodic benefit-risk evaluation reports and development safety update reports, as applicable.
Help ensure that pharmacovigilance data submitted to health authorities are correct, complete, traceable and submitted within applicable timelines.
Support reconciliation of safety data with product complaints, medical information, organized data collection programs and other identified sources.
Safety Data Sources and Business Partnerships
Act as a safety advisor to affiliate cross-functional teams when establishing or managing activities in which safety information may be identified or handled.
Ensure that all local sources of adverse events and other safety information are identified and that mechanisms are in place for their collection, transfer and reconciliation with Global Patient Safety.
Partner with Regional Pharmacovigilance teams to develop, review and maintain Safety Data Exchange Agreements and other pharmacovigilance agreements in line with AbbVie procedures and Saudi requirements.
Maintain the local inventory of pharmacovigilance agreements in the designated system and monitor compliance with contractual safety obligations.
Coordinate and document pharmacovigilance training for partners, service providers and other contracted parties according to the relevant agreement and local requirements.
Pharmacovigilance Training
Maintain oversight of the affiliate pharmacovigilance training plan and training matrix.
Ensure that local pharmacovigilance personnel, affiliate employees and relevant contractors complete required corporate and local pharmacovigilance training within defined timelines.
Develop or adapt local training materials when required and retain appropriate training records.
Promote clear understanding across the affiliate of individual responsibilities for identifying and reporting safety information.
Audits and Inspections
Support internal pharmacovigilance audits, audits of service providers or third parties and inspections conducted by health authorities.
Coordinate inspection readiness activities and ensure prompt access to relevant procedures, records, system information, metrics and subject matter experts.
Assist with responses to audit and inspection observations, including development and timely completion of corrective and preventive actions.
Act as a local pharmacovigilance inspection contact when required under the National QPPV Deputy designation or approved back-up arrangement.
Regulatory Intelligence and Compliance
Act as a subject matter expert on Saudi pharmacovigilance regulations, guidance and policy.
Monitor Saudi health authority websites and other approved sources for new or revised pharmacovigilance requirements and relevant safety information.
Lead or support documented impact assessments of local and applicable regional pharmacovigilance intelligence, communicate required changes and monitor their implementation.
Ensure local pharmacovigilance obligations are met and escalate new, urgent or ad hoc issues to the Affiliate Safety Representative, Regional Pharmacovigilance Lead and QPPV Network, as appropriate.
Attend QPPV Network meetings or review meeting summaries and implement relevant local actions.
Risk Management and Benefit Risk
Support the Affiliate Safety Representative and Affiliate Medical Director in leading local risk management activities in line with Saudi requirements.
Coordinate receipt and distribution of Risk Management Plans, Core Implementation Strategies and additional risk minimization measures to relevant affiliate stakeholders.
Maintain sufficient knowledge of applicable Risk Management Plans and the benefit-risk profiles of company products to perform the role effectively.
Coordinate with affiliate, regional and global stakeholders during the development or revision of local Risk Management Plans, RMP annexes, Local Implementation Plans and country-specific additional risk minimization measures.
Assess and implement Core Implementation Strategies and accompanying additional risk minimization measures, when applicable, and maintain evidence of implementation and effectiveness activities.
Maintain awareness of the content of applicable Risk Management Plans, conditions or obligations attached to marketing authorizations, safety commitments and post-authorization safety studies requested by the Saudi health authority.
Safety Monitoring and Evidence Generation
Maintain an overview of product safety profiles and emerging safety concerns for company products marketed in Saudi Arabia.
Review relevant product safety updates from the QPPV Office and Global Patient Safety and assess their local implications.
Support local safety monitoring, signal management and additional monitoring activities in line with health authority requirements and the global pharmacovigilance system.
Coordinate local pharmacovigilance requirements for pre- and post-authorization studies, including safety reporting, development safety update report submissions, pharmacovigilance agreements and updates to applicable national pharmacovigilance system files.
Support review and sign-off of post-authorization safety study protocols when assigned and permitted by the applicable process.
Communicate relevant safety evidence and benefit-risk information to affiliate stakeholders when it may affect medical, regulatory or business decisions.
Launch Readiness and Pharmacovigilance Advocacy
Support the Affiliate Safety Representative in developing a local safety and pharmacovigilance strategy for product and indication launches.
Provide proactive pharmacovigilance input to launch plans and act as a safety advisor to relevant affiliate teams.
Support local pharmacovigilance advocacy activities in line with AbbVie, Global Patient Safety and QPPV Office guidance.
Delegation and Medical Support
Specific pharmacovigilance tasks may be delegated only to appropriately qualified and trained individuals. Delegation must be documented and remain under the oversight of the National QPPV or National QPPV Deputy, as applicable.
Where the appointed National QPPV Deputy has not completed medical training, ready access to appropriately qualified medically trained personnel must be formally documented in both parties' job descriptions or other approved role documentation.
Delegation of individual tasks does not remove accountability for maintaining oversight of the local pharmacovigilance system and the safety profiles of products within scope.
QualificationsQualifications and Experience
Bachelor's degree in pharmacy or medicine is required.
Meets all current Saudi health authority eligibility, professional registration, location, notification and training requirements applicable to the National QPPV Deputy designation at the time of appointment.
At least two years of experience in the pharmaceutical industry in a pharmacovigilance role is required.
Documented theoretical and practical knowledge of pharmacovigilance activities and the operation of a pharmacovigilance system.
Demonstrated experience with adverse event and individual case safety report processes, periodic or aggregate reporting, risk management, pharmacovigilance quality systems, training, audits or inspections and regulatory compliance.
Sound knowledge of Saudi pharmacovigilance legislation, Saudi Good Pharmacovigilance Practice requirements and applicable regional or global pharmacovigilance standards.
Documented training sufficient to oversee and support maintenance of an effective local pharmacovigilance system. Any additional training mandated by the Saudi health authority must be completed and maintained.
Ability to understand product safety profiles, emerging safety concerns, benefit-risk information and the scientific basis of risk management decisions.
Fluency in written and spoken English is essential for communication with Global Patient Safety, regional teams and global functions.
Fluency in written and spoken Arabic is required for communication within the affiliate and with the Saudi health authority.
Excellent written and verbal communication and presentation skills.
Strong planning, organization and prioritization skills, with the ability to manage multiple time-sensitive regulatory obligations.
Sound judgment, attention to detail and a demonstrated sense of urgency in managing safety and compliance matters.
Strong scientific acumen and the ability to understand and apply scientific and regulatory concepts.
Additional Information
Authority and Key Relationships
The role reports to the Affiliate Safety Representative / Pharmacovigilance Lead. It must have direct access to relevant affiliate leadership, the Affiliate Medical Director, Regional Pharmacovigilance leadership, the QPPV Office and Global Patient Safety to raise safety or compliance concerns and obtain timely support.
Internal Relationships
Affiliate Medical Affairs, Regulatory Affairs, Clinical, Quality Assurance, Commercial, Marketing, Sales, Operations, Customer Service, Medical Information and Product Quality personnel.
Global Patient Safety, including the Regional Pharmacovigilance Lead, Area Pharmacovigilance Head, Area Pharmacovigilance Product Lead, QPPV Office, Risk Management teams and other relevant safety functions.
External Relationships
Saudi health authorities responsible for product safety, including pharmacovigilance inspectors.
Ethics committees, investigators, healthcare professionals, consumers and patients, as appropriate and in accordance with AbbVie procedures and local requirements.
Distributors, licensing partners, service providers and other third parties that may identify, receive, process or exchange safety 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.
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