Oversight of the Pharmacovigilance System
- Ensures that PV processes, procedures and systems are in place to comply with AbbVie Global PV procedures and with local and/or regional PV regulations.
- Maintains oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by PSEQ the Regional PV Teams and/or outsourced partners, in collaboration with Regional PV Leaders who oversee day-to-day operational PV activities.
- (National QPPV / back-up National QPPV only) Maintains oversight of AbbVie’s PV System Master File (PSMF) with the authority to ensure that the information contained is an accurate and up-to-date reflection of the PV system.
Quality Management System
- Partners with PSEQ the Regional PV Teams to:
- Ensure Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations.
- Manage any non-conformity and/or planned departures from corporate and/or local PV procedures according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
- Maintain oversight of the PV training plan and ensure training compliance of local PV personnel and other affiliate personnel with corporate and local PV training requirements.
- Oversee training compliance of partner company staff according to local contract requirements.
Adverse Event & Periodic Safety Reporting
- Maintains oversight of the PV system and ensures that processes, procedures and systems are in place for intake, processing, conducting follow up, translation and reconciliation of adverse events and other safety information reportable to PPS GPS from spontaneous and solicited sources as well as from clinical studies.
- Partners with the Regional PV Teams in PSEQ GPS to ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agencies, Ethics Committees and Investigators, in compliance with corporate PV procedures and with local and regional PV regulations as required.
Audits and Inspections
- Serves as the Affiliate Lead and point of contact for affiliate PV audits and Regulatory Authority PV inspections, demonstrating understanding of the overall AbbVie PV system and how Global PV processes and PSEQ the GPS Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements.
- Collaborates with the GPS PSEQ Regional PV Teams in to manage managing audits of processes executed by the Regional PV Teams and as well as audits of affiliate service providers and third parties.
- Supports PSEQ Collaborates with GPS Regional PV Teams in the development of CAPA in response to observations and the tracksing actions to completion in a timely manner.
Partnership with business partner with possibility for identification and/or handling of safety information
- Acts as key safety advisor for affiliate cross-functional partners on safety topics to address business needs and ensure ensuring that business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements, and that applicable PV and safety data exchange agreements are implemented.
- Partners with PSEQ the GPS Regional PV Teams to ensure that:
- All sources of adverse events and other safety information are identified at the local level and mechanisms are in place for collection and collation of all data by PSEQ GPS.
- Content of local Safety Data Exchange Agreements (SDEAs) and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS GPS PV Agreements Database.
- Compliance with local agreements.
PV Training
- Collaborates with PSEQ the GPS Regional PV Teams to ensure overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required.
Legislation Intelligence
- Collaborates with PSEQ the GPS Regional PV Teams to ensure monitoring of local (and applicable regional/area) PV-relevant hard intelligence, and leads leading the impact assessment of such intelligence them.
Risk Management
- Leads the Affiliate Risk Management Team (ARMT) local risk management activities in alignment with local regulations with the Affiliate Medical Director (AMD).
- Coordinates the receipt and distribution of Risk Management Plans (RMPs), Core Implementation Plan Strategy (CIS CIP) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders ARMT members.
- Develops a deep knowledge of the Risk Management Plans (RMPs) to obtain information on the risk/benefit profile of products.
- Liaises with ARMT & Benefit Risk Management (BRM) Team the affiliate stakeholders and the Office of Risk Management and where applicable, seek involvement of relevant PSEQ global stakeholders during the development or revision of the local RMP or RMP COUNTRY Specific Annex (if applicable), Local Implementation Plan (LIP) & local or country-specific aRMM.
- Performs the assessment and implementation of the CIS and accompanying aRMM, when applicable.
Safety Monitoring and Evidence Generation
- Maintains an overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and maintains awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency.
- Be a key driver in the generation and interpretation of safety evidence across the product lifecycle.
- Understands and monitors incoming local safety data and communicate changes or potential concerns to the PSEQ GPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
- Through the oversight of pharmacovigilance processes and the active monitoring of safety data, the ASR ensures that robust evidence is generated to inform risk management, regulatory submissions, and product safety profiles.
- Reviews summary reports of local research-related activities and communicates any safety insights/findings with Medical Teams and PSEQ GPS.
- Leads product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources.
Launch Readiness
- Sets a solid local safety and PV strategy incorporating proactive PV contributions to ensure a successful product or indication launch at the affiliate.
- Acts as key safety advisor for affiliate cross-functional partners on safety topics.
PV Advocacy
- Maintains awareness, oversight and actively contributes to assessing the impact of new legislations on the PV system. Drives AbbVie PV advocacy efforts through strong internal and external collaboration including and engagement with in local trade associations, industry network, and with Regulatory Agencies.
- Collaborates on internal and external PV advocacy efforts, in alignment with the AbbVie, PSEQ GPS, and QPPV Office advocacy guidance.
After Hours Availability & Business Continuity
- Ensures that a local Affiliate PV Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV.
- (National QPPV / back-up National QPPV only) Ensures availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis, if applicable, and that an after-hours process is in place for the reporting of AEs and that a Disaster Recovery Plan/Business Continuity Plan is established to allow for continuation of critical business processes for PV.