Affiliate Safety Representative - North Africa

JOB SUMMARY:

In collaboration with the AMD and MENA Regional PV lead (RPL), Lead the coordination and execution of all aspects of pharmacovigilance (PV) at the affiliate level to ensure that AbbVie’s statutory and ethical responsibilities are met.

Acts as the Affiliate’s main contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Global Patient Safety (GPS) function.

Serves as the National Qualified Person for Pharmacovigilance (NQPPV) when applicable, with sufficient authority to influence the performance of the quality system and pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements. Detailed role profile outlining the specific accountabilities of the role are described in the country attestation form.

Provides strategic leadership to manage and support the PV team in executing assigned responsibilities.

Supports recruitment, on-boarding, training, development through coach and mentoring, performance management, and succession planning of appropriately skilled PV staff

KEY DUTIES AND RESPONSIBILITIES:

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 the Regional PV Teams and/or outsourced partners, in collaboration with Regional PV Leaders who oversee day-to-day operational PV activities
• 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.
• Delegates specific tasks under supervision and with documentation, to appropriately qualified and trained individuals, provided that the QPPV maintains system oversight and overview of the safety profiles of all products.

Quality Management System

Partners with 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, follow up, translating and reconciling adverse events and other safety information reportable to GPS from spontaneous and solicited sources and from clinical studies.
• Partners with the Regional PV Teams in 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, to comply 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 GPS Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements.
• Collaborates with the GPS Regional teams to manage audits of processes executed by the GPS Regional PV Teams as well as audits of affiliate service providers and /third parties.
• Collaborates with GPS Regional teams in the development of CAPA in response to observations and the tracking 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 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 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 GPS Regional team.
  • 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 GPS PV Agreements Database.
  • Compliance with local agreements.

PV Training

• Collaborates with the GPS PV Regional 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 the GPS Regional PV teams to ensure monitoring of local (and applicable regional/area) PV-relevant hard intelligence, and leads the impact assessment of such intelligence.

Risk Management

• Leads the local risk management activities in alignment with local regulations with the AMD.
• Coordinates the receipt and distribution of Risk Management Plan (RMP), Core Implementation strategy (CIS) and additional risk minimization measures (aRMM) to relevant affiliate stakeholders.
• Develops a deep knowledge of the RMPs to obtain information on the risk/benefit profile of products.
• Liaises with affiliate stakeholders & office of Risk Management (ORM) Team and where applicable, seek involvement of relevant global stakeholders during development or revision of the local RMO or RMP  Annex (if applicable), Local implementation strategy (LIS), Country Dissemination Plan (CDP) & local aRMM.
• Performs the assessment and implementation of the CIS and accompanying aRMM, when applicable

Safety Monitoring & 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 GPS Regional team, 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 communicate any safety insights/findings with Medical Teams and GPS Regional team.
• 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 & PV strategy incorporating proactive PV contributions to ensure a successful product / 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 and drives Abbvie PV advocacy efforts via strong internal & external collaboration including engagement with local trade associations, industry network, and with Regulatory Agencies.
• Collaborates on internal and external PV advocacy efforts, in alignment with the AbbVie, GPS Regional team, 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.
• 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.

Authority and reporting lines:

• This position reports into the Affiliate Medical Director.
• Member of the Affiliate Medical Leadership Team in order to influence decisions which can potentially impact the PV system locally.