PRIMARY FUNCTION:
Responsible to ensure that all aspects of Pharmacovigilance at the affiliate level meets AbbVie’s statutory and ethical responsibilities, and complies with local and regional PV regulations, for the applicable product portfolio. Acts as the Affiliate’s lead for pharmacovigilance matters with the National Regulatory Agency and AbbVie PPS (Pharmacovigilance and Patient Safety) function.
To provide strategic leadership to manage and support the Pharmacovigilance (PV) team in executing assigned responsibilities.
Serve as the local Qualified Person for Pharmacovigilance (QPPV) in Colombia, Panamá, El Salvador & NQPPV Back-up in Perú and Guatemala, 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.
RESPONSIBILITIES:
Leadership and management
- Build and maintain effective business relationships across the affiliate to support the implementation of patient safety standards.
- Maintain an environment of continuous improvement to optimize the affiliate PV system and contribute to regional and global process improvement initiatives, working with PPS subject matter experts.
- Support recruitment, on-boarding, training, development through coach and mentoring, performance management, and succession planning of appropriately skilled PV staff.
- Lead a diverse and remote team operating across multiple geographical locations.
- Communicate effectively to achieve affiliate/regional/area cross-functional alignment and engagement for a better understanding of the PV hub model and how to leverage it for success.
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
- Maintain oversight of the performance of all activities that fulfil local and applicable regional PV regulations, including those performed by Regional PV Teams and/or outsourced partners..
- 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.
- Maintain awareness and monitor local post-marketing and clinical PV legislation, to ensure PV legislation changes are communicated to relevant stakeholders for review, impact assessment, implementation and mitigation according to global procedures.
- Develop and maintain PV Hub governance tools to ensure clear allocation of responsibilities across stakeholders for effective PV Hub Oversight.
Quality Management System:
Partners with Regional PV Teams to:
- Ensure the 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 t 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, translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies.
- Partners with Regional PV Teams to e nsure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Regulatory Agency, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.
Audits and Inspections:
- 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 Regional PV Teams are set-up and structured, supporting the fulfilment of local legal requirements.
- Collaborate with PSEQ Regional teams in managing audits of processes executed by the PSEQ Regional PV Teams and audits of affiliate service providers/third parties.
- Supports PSEQ 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 to address business needs and ensure 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 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.
- content of local SDEAs and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS PV Agreements Database.
- compliance with local agreements.
PV Training
- Collaborates with PSEQ 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 PSEQ Regional teams to ensure monitoring of local (and applicable regional/area) PV-relevant hard intelligence, leading the impact assessment of them.
Risk Management:
- Leads the Affiliate Risk Management Team (ARMT) with the AMD
- Coordinates the receipt and distribution of RMP, Core Implementation Plan (CIP) and additional risk minimization measures (aRMM) to 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 and where applicable, seek involvement of relevant PSEQ stakeholders during development or revision of the COUNTRY Specific Annex (if applicable), Local Implementation Plan (LIP) & local aRMM.
- Performs the assessment and implementation of the CIP and accompanying aRMM, when applicable
Safety Monitoring:
- Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and 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.
- Understand and monitor incoming local safety data and communicate changes or potential concerns to the PPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
- Reviews summary reports of local research-related activities and communicate any safety insights/findings with Medical Teams and PSEQ.
- Leads product safety communication and education initiatives for local cross-functional teams on major PV topics and on local data sources.
- Ensure a full and prompt response to regulatory agency requests for provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
- Delegate 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.
- Ensure that as QPPV, when applicable, within the PV Hub, delegate 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.
Launch Readiness
- Sets a solid local safety & PV strategy incorporating proactive PV contributions to ensure a successful product / indication launch at the affiliate.
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 and engagement in local trade associations, industry network, and with Regulatory Agencies.
- Collaborates on internal and external PV advocacy efforts, in alignment with the AbbVie, PSEQ, and QPPV Office advocacy guidance.
After Hours Availability & Business Continuity:
- Ensure availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis.
- Ensure that an after-hours process is in place for the reporting of AEs.
- Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV.
INTERNAL / EXTERNAL CONTACTS AND INTERACTIONS:
- Affiliate medical, regulatory affairs, clinical, quality assurance and customer service personnel.
- Affiliate Marketing, Sales and Operations personnel to ensure that all employees are trained and understand their responsibilities for reporting of any safety information.
- National Regulatory Agency responsible for product safety.
- Pharmacovigilance and Patient Safety including but not limited to Regional PV Lead, Area PV Head, Area PV Product Lead, QPPV Office and Risk Management Teams.
- Healthcare Practitioners, consumers and patients.
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.
- LOCATION: should be based in country Colombia.
- Medical degree (or equivalent). For Colombia the National QPPV must be Medical or pharmacy degree with knowledge in Pharmacovigilance.
- Minimum of 5 years’ experience working in the pharmaceutical industry in a drug safety role is strongly preferred for the Affiliate Safety Representative role but is less critical for the backup ASR role at least two years’ experience working in the pharmaceutical industry in a pharmacovigilance role is required.
- Minimum 2 years’ experience in management of direct reports.
- Adequate theoretical knowledge and practical experience of PV activities and system under purview (as stipulated in local guidance) and sound understanding of the regulatory and PV monitoring requirements for assigned territory(ies) that comply with any specific training requirements mandated by relevant regulatory agencies.
- Excellent written and spoken communication and presentation skills.
- Fluency in written and oral English is essential to facilitate communications with Pharmacovigilance and Patient Safety, Area/Regional Medical and other headquarters functions.
- Fluency in written and oral local language a requirement to facilitate communications within the affiliate medical department, and with the National Regulatory Agency.
- High customer orientation
- Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity
- Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency.
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