Countries and Regions PV Manager

• The Sobi GPV outreach strategy to Sobi country and regional PV developing, supporting, and driving excellence in post-approval pharmacovigilance activities related to Sobi and Sobi’s partner products, to ensure local compliance with Sobi/Partner PV system requirements.
• Provide input to Sobi’s geo-expansion activities, to ensure timely implementation of a robust, compliant and efficient PV system, for new products and new markets
• Interaction with vendors contracted to perform local and regional PV activities in order to drive local Pharmacovigilance (PV) performance, deliver compliant, effective, efficient and business appropriate standards and processes, and supporting oversight and audit/inspection readiness.
• Facilitation and communication of PV related activities and projects between GPV and local teams.

• Contribute to the effective business interface between Sobi GPV and strategic vendors for Sobi local and regional PV activities, including oversight of vendor compliance in assigned countries
• Working closely with Sobi global function stakeholders and local Sobi teams to ensure effective communication, collaboration and issue resolution
• Point of contact for GPV and other teams for assigned countries
• Promote and implement continuous improvement activities across all areas related to countries and regions PV activities to optimise quality and productivity, including process improvement and CAPA management and implementation
• Work closely with Global Process Owners to ensure local implementation of global pharmacovigilance procedures
• For assigned countries, primary GPV point of contact for local teams for Pharmacovigilance aspects
• Ensures strong relationships with country PV staff to maximise opportunities for Pharmacovigilance, Sobi/partner products and patients.
• Identify, assess and escalate risks related to country pharmacovigilance activities to the Head of Countries & Regions, QPPV and other teams as appropriate and contribute to put in place actions to address identified risks.
• Ensures compliance with processes for quality oversight of local PV activities, including outsourcing activities, review of local PV related Standard Operations Procedures (SOPs), training and implementation of PV related SOPs and procedures, local literature review, aRMM and other activities supported by Sobi local PV contacts through interaction with Global Process Owners
• Responsible for ensuring CAPAs related to PV activities in the assigned countries are appropriate to the issue concerned and closed on time.
• Maintains a high degree of understanding and awareness of new Pharmacovigilance trends and developments and works with GPV, local PV and vendors to ensure Sobi PV activities remain current
• Supports the management and maintenance of the Pharmacovigilance System Master File (PSMF) including local and partner PSMFs, through delivery of regional PV information as required by the PSMF Coordinator.

• Contributes to continuous improvement of GPV processes, systems and standards

• Contributes to the GVP audit strategy and audit schedule.
• Supports the PV audit and inspection readiness activities at local level.
• Supports PV inspections and audits (internal/external), including pre-inspection/audit request and support during inspections/audits.
• Supports responses and CAPAs to inspections and audits with focus on affiliate level and manage close out of CAPAs.

• University level qualification in biosciences, healthcare or pharmacy.
• At least 5 years professional work experience in the Pharmaceutical industry with at least 2 years of experience within Pharmacovigilance department.

• Pharmacovigilance experience from working within both the local and global level
• System and process development, implementation and improvement

• Expert knowledge of PV related regulatory requirements, including understanding of PV processes, and international guidelines (including Good Pharmacovigilance Practices (GVP)) and ICH Guidelines
• Works across teams to develop holistic understanding of situations and requirements, in order to deliver solutions that work across stakeholders
• Strong collaborator and problem solver
• Quality mindset inc CAPA management
• Fluent in English
• Computer literate

• Strong communication skills, including across geographies and functions
• Strong analytical/problem-solving skills and attention to detail
• Ability to manage multiple activities simultaneously
• Ability to independently plan, organise, coordinate, and execute assigned tasks
• Understanding the requirements of diverse stakeholders and conflict resolution management
• Delivery focused with ability to exercise judgment, make decisions, and take action to complete assignment.
• Able to work collaboratively

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