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Form of work Description:
This position is accountable for the successful strategy, oversight and execution of deliverables for the Pharmacovigilance (PV) Analytics and Safety Systems Team. The role is critical to Global Pharmacovigilance to support the overall global safety surveillance of client products and ensuring compliance to global regulatory requirements and client policies and standards.
Job Duties & Responsibilities:
•Accountable to ensure regulatory safety case and aggregate reporting compliance is sustained at a level that meets or exceeds the industry standard and satisfies regulatory requirements globally.
•Provides value-added safety data management to enable rapid, informed decisions to be made by development and marketed product teams, based on accurate safety data.
•Accountable and has oversight for all aspects of global pharmacovigilance operations (ICSR management study oversight from PV perspective, GVP systems & analytical oversight & GVP compliance).
•Oversees Vendor and Alliance Management to ensure compliance with global
•Pharmacovigilance regulations and guidelines, while driving efficiencies & assuring high quality.
•Responsible for department strategic and operational goals.
•Ensure processes are demonstrably compliant with global regulatory requirements with regards to pharmacovigilance, enabling a satisfactory outcome of regulatory PV inspection anywhere in the world.
•Leads and systematically enhances all GPV Operations activities globally for collecting, organizing adverse events and the reporting of ICSRs and aggregated reports to Regulatory authorities of adverse events for global clinical trials and post marketing activities.
•Represent GPV internally with functions and senior management, and externally with regulatory agencies and strategic partners.
•Independently represent the PV Operations function during regulatory PV inspections, responses and corrective actions and plans, worldwide.
•Recruit and develop a high functioning team of 14-20 PV professionals, ensuring their effective management in line with HR policies.
•Provide strategic, mid- and long-term vision to guide the development of new departmental and cross function processes including technology and compliance initiatives, in a continuously changing external regulatory environment; ensure implementation of CAPAs; and evaluate opportunities for, and implement, upgrades and enhancements.
•Advocate for Global Pharmacovigilance and Drug Safety by building strong relationships with Clinical
•Operations, Regulatory Affairs, Clinical, Quality Assurance, Manufacturing, Medical Affairs, and Medical
•Monitors to ensure and continually improve pharmacovigilance
Subject Matter Expert with regards to global pharmacovigilance regulations and requirements.
•Propose and enable country and regional PV solutions based on central global PV strategies, including evaluate legislative changes affecting PV and develop strategies to support the patient safety at global, regional and local country level.
•Oversee the development and implementation of all associated SOPs, policies, guidelines & working instructions.
•Enable EU-QPPV to achieve PV oversight.
•Support PV due diligence with regards to product acquisition at local level or new business venture.
•Provide oversight of SDEA & PVA process for vendors and third party contractors.
Essential Qualifications
•Proven ability to convert strategic vision into transformational solutions
•Proven leadership skills related to development and execution of plans and processes: ability to continuously enhance sub-optimal systems and processes into state-of-the-art, compliant systems and processes
•Intimate, deep knowledge of safety systems including Argus and associated tools and applications
•Comprehensive, deep knowledge and understanding of Global PV Regulations and impact of emerging regulatory requirements and their implication
•Strong matrix and direct people management capabilities
•Strong networking and influential skills to deal with potential conflict of stakeholders with the ability to bring a diverse group to a common decision
•Demonstrated success in representing the company in pharmacovigilance inspections and audits
•Proven ability to analyze situations and negotiate solutions in many different cultural contexts
•Proven experience in group facilitation with the ability to drive teams to make decisions and achieve deliverables within agreed parameters and timelines
•Ability to interact effectively with staff and peers of multiple disciplines both within and outside the company) globally
•Ability to lead in a high pressure, fast paced and changing environment to ensure objective are met on time and achieved with budget allocation
Qualifications for Director:
Education
• Advanced degree preferred with minimum of 6 years' of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in clinical or drug safety/ pharmacovigilance databases and systems
OR
• Master's degree with minimum of 7 years' of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in clinical or drug safety/ pharmacovigilance databases and systems
OR
• Bachelor's degree and minimum of 9 years' of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in clinical or drug safety/ pharmacovigilance databases and systems
AND
• Four (4) years' of managerial experience directly managing people and/or leadership experience leading teams, projects or programs
Preferred Qualifications for ED
•Doctorate preferred: MD, PhD or PharmD
This position is accountable for the successful strategy, oversight and execution of deliverables for the Pharmacovigilance (PV) Analytics and Safety Systems Team. The role is critical to Global Pharmacovigilance to support the overall global safety surveillance of client products and ensuring compliance to global regulatory requirements and client policies and standards.
Job Duties & Responsibilities:
•Accountable to ensure regulatory safety case and aggregate reporting compliance is sustained at a level that meets or exceeds the industry standard and satisfies regulatory requirements globally.
•Provides value-added safety data management to enable rapid, informed decisions to be made by development and marketed product teams, based on accurate safety data.
•Accountable and has oversight for all aspects of global pharmacovigilance operations (ICSR management study oversight from PV perspective, GVP systems & analytical oversight & GVP compliance).
•Oversees Vendor and Alliance Management to ensure compliance with global
•Pharmacovigilance regulations and guidelines, while driving efficiencies & assuring high quality.
•Responsible for department strategic and operational goals.
•Ensure processes are demonstrably compliant with global regulatory requirements with regards to pharmacovigilance, enabling a satisfactory outcome of regulatory PV inspection anywhere in the world.
•Leads and systematically enhances all GPV Operations activities globally for collecting, organizing adverse events and the reporting of ICSRs and aggregated reports to Regulatory authorities of adverse events for global clinical trials and post marketing activities.
•Represent GPV internally with functions and senior management, and externally with regulatory agencies and strategic partners.
•Independently represent the PV Operations function during regulatory PV inspections, responses and corrective actions and plans, worldwide.
•Recruit and develop a high functioning team of 14-20 PV professionals, ensuring their effective management in line with HR policies.
•Provide strategic, mid- and long-term vision to guide the development of new departmental and cross function processes including technology and compliance initiatives, in a continuously changing external regulatory environment; ensure implementation of CAPAs; and evaluate opportunities for, and implement, upgrades and enhancements.
•Advocate for Global Pharmacovigilance and Drug Safety by building strong relationships with Clinical
•Operations, Regulatory Affairs, Clinical, Quality Assurance, Manufacturing, Medical Affairs, and Medical
•Monitors to ensure and continually improve pharmacovigilance
Subject Matter Expert with regards to global pharmacovigilance regulations and requirements.
•Propose and enable country and regional PV solutions based on central global PV strategies, including evaluate legislative changes affecting PV and develop strategies to support the patient safety at global, regional and local country level.
•Oversee the development and implementation of all associated SOPs, policies, guidelines & working instructions.
•Enable EU-QPPV to achieve PV oversight.
•Support PV due diligence with regards to product acquisition at local level or new business venture.
•Provide oversight of SDEA & PVA process for vendors and third party contractors.
Essential Qualifications
•Proven ability to convert strategic vision into transformational solutions
•Proven leadership skills related to development and execution of plans and processes: ability to continuously enhance sub-optimal systems and processes into state-of-the-art, compliant systems and processes
•Intimate, deep knowledge of safety systems including Argus and associated tools and applications
•Comprehensive, deep knowledge and understanding of Global PV Regulations and impact of emerging regulatory requirements and their implication
•Strong matrix and direct people management capabilities
•Strong networking and influential skills to deal with potential conflict of stakeholders with the ability to bring a diverse group to a common decision
•Demonstrated success in representing the company in pharmacovigilance inspections and audits
•Proven ability to analyze situations and negotiate solutions in many different cultural contexts
•Proven experience in group facilitation with the ability to drive teams to make decisions and achieve deliverables within agreed parameters and timelines
•Ability to interact effectively with staff and peers of multiple disciplines both within and outside the company) globally
•Ability to lead in a high pressure, fast paced and changing environment to ensure objective are met on time and achieved with budget allocation
Qualifications for Director:
Education
• Advanced degree preferred with minimum of 6 years' of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in clinical or drug safety/ pharmacovigilance databases and systems
OR
• Master's degree with minimum of 7 years' of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in clinical or drug safety/ pharmacovigilance databases and systems
OR
• Bachelor's degree and minimum of 9 years' of directly related experience (Management Information Systems, Computer Science, Informatics) with experience in clinical or drug safety/ pharmacovigilance databases and systems
AND
• Four (4) years' of managerial experience directly managing people and/or leadership experience leading teams, projects or programs
Preferred Qualifications for ED
•Doctorate preferred: MD, PhD or PharmD
