Head of PV Compliance

Head of PV Compliance

Teva

Flexible Location, Europe

Purpose

The Senior Director, Head PV Compliance is accountable for and provides strategic leadership for Teva’s global PV quality management system (including but not necessarily limited to, regulatory intelligence, procedures, change control, the PSMF, trainings, PV system performance incl. metrics, Risk Cards, governance, inspection readiness and inspection management, deviations and CAPAs, documentation practices), and for PV agreements including their implementation oversight.

The Head PV Compliance reports to the Head of Global Patient Safety & Pharmacovigilance (PV) and is a member of the global Patient Safety Leadership Team.

The Head PV Compliance directly manages and oversees a global team of PV Compliance Leaders, providing strategic leadership with respect to defining and achieving industry standards of compliance with PV regulations and requirements, operational excellence, resourcing strategy, driving change towards continuous improvement, and the strategic and personal development of the team.

The Head PV Compliance is an innovative and collaborative problem-solver who can think strategically and inspire the Global PV Compliance team and the broader PV and Teva organization about the role of PV compliance in support of Teva’s patients and products.

Main responsibilities

• Define and lead the global policy and strategy for Teva Patient Safety Pharmacovigilance for the PV quality management system, as described above;
• Oversee and maintain Teva's global PV quality management system, identifying and raising awareness of areas relevant for PV and/or Patient Safety which need improvement for full compliance with all internal and external PV requirements;
• Develop and enhance the global PV quality management system for the future;
• Ensure PV agreements exist as required (not more, not less), and there is full oversight and evidence of their implementation;
• Ensure compliance with worldwide pharmacovigilance regulatory requirements and corporate PV standards at all levels of the PV organization;
• Lead a global team to ensure that the Compliance function is operationalized according to the highest industry standards and that all compliance colleagues are informed and fully compliant with company policies and SOPs;
• Coach, develop and mentor employees. The position is accountable for the competency and development of employees within PV Compliance;
• Evaluate the effectiveness of PV compliance structures and processes and plan and execute changes for greatest success in alignment with the Global PV operating model and plans;
• Oversee and approve all Pharmacovigilance procedures as required per internal standards;
• Assess Teva's global PV quality management system equipment and systems to maximize efficiency;
• In collaboration with other business units, define and achieve annual goals, objectives and KPIs;
• Lead GVP Inspection readiness activities in Teva organization;
• Lead Teva through GVP inspections, including health authorities and other third parties inspections.

Qualifications

• Minimum Master's degree in Sciences or in nursing/paramedical studies;
• Minimum of 10 years of PV experience in the Pharmaceutical industry, including a large international organization;
• At least 5 years of direct people leadership experience;
• Extensive experience in handling Health Authority Inspections;
• Computer literacy (Microsoft Office) and work with databases;
• Fluent in English.

Job-specific competencies

• Leadership: The ability to empower, grow, develop and inspire high performing teams and individuals by providing them with clear direction linked to organizational goals;
• Results and Performance-Driven: Assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the patient central to all thinking; keeps the focus on driving patient impact;
• Strong Interpersonal and People Skills: Proven background interacting with individuals at a variety of functional levels with both internal and external personnel and the ability to perform cross-functionally;
• Excellent Communication Skills, both written and Oral: Communication style should be diplomatic and direct, but not confrontational. He or she must be able to summarize information in an articulate, clear, tangible, manner both in written form and orally.

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