JOB SUMMARY
Primary Purpose / Regulatory Responsibilities:
• Responsible for ensuring Pharmacovigilance systems, operations and procedures are in place within the local organization for all territories assigned to the Affiliate as delegated
• Back up (or primary when delegated) contact for pharmacovigilance at the Affiliate
• Support the operational management of 1-2 medium or 1 highly complex Affiliate/country
MAJOR RESPONSIBILITIES
Support the Local Safety Officer to ensure oversight and management of Affiliate PV responsibilities as delegated/applicable:
Pharmacovigilance System
• Implement and maintain a pharmacovigilance system for the products authorized in the territory and ensure compliance with applicable regulatory and company requirements;
• Identify and clearly articulate evolving local needs (regulation changes, eco-system changes, etc.) impacting Pharmacovigilance and as required work collaboratively with corporate Pharmacovigilance teams to develop and implement solutions; Provide input to harmonize global/local processes and to secure compliance; Work in close collaboration with corporate Pharmacovigilance teams to ensure that local obligations are managed and compliance to local authorities is maintained and secured;
• Maintain quality management system related to pharmacovigilance, including management of Standard Operating Procedures (SOPs), Associated Instructions (AIs) and documents (e.g. forms, templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs; Maintain oversight of local deliverables delegated to service providers;
• Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate.
• Maintain a functional connection with the Qualified Person for Pharmacovigilance (Global/EEA QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Pharmacovigilance;
• Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office, either directly or through local delegations (colleagues or third parties);
• Ensures that adequate back-up processes are available
Proactive Regulatory Intelligence
• Maintain thorough knowledge of the local current pharmacovigilance regulatory requirements and landscape plus proactively monitor for emerging regulations and communicate such to corporate teams (including EEA QPPV), local stakeholders;
• Perform Impact assessment, gap analysis and implementation strategy for new or updated regulations and notify Global/EEA QPPV (as applicable), corporate Pharmacovigilance and relevant stakeholders.
Health Authority inspections and Audit readiness
• Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Pharmacovigilance and Quality Assurance;
• Participate in and manage pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation of respective Corrective Actions Preventive Actions (CAPAs);
Stakeholder Management
• Engage in transversal collaboration with affiliate and corporate stakeholders to secure pharmacovigilance compliance;
• Engage external stakeholders e.g. scientific community, patient advocacy groups, regulators and pharma industry for insights that leads to solutions for patients.
Other accountabilities for the role may include some or all the tasks, responsibilities such as –
• Support the LSO in operational management of 1-2 medium or 1 high complexity Affiliate/country.
• Collaborate as Deputy LSO for another country outside of direct Affiliate responsibility or another Affiliate as applicable
• Act as back-up SME for other Affiliates/countries
• Support effective, smooth management of Partnerships/vendors additionally for at least 1 countries/Affiliates