Global Head Pharmacovigilance Quality Assurance
hace 2 semanas
Global Head Pharmacovigilance Quality Assurance:
Spain
About the role
Location:
Hybrid. Barcelona, Spain.
Novartis is able to offer relocation support for this role
About the role:
We are seeking a strategic and administrative leader to oversee the Pharmacovigilance Quality Assurance (PVQA) organization within the Novartis Patient Safety & Pharmacovigilance Department.
In this role, you will provide comprehensive expertise and oversight of PV Quality, ensuring compliance with regulations and the Novartis Quality Management System.
You will be responsible for global end-to-end Pharmacovigilance and Device Vigilance Systems, as well as commercial and patient-focused activities across all Novartis Enterprises and countries.
Key responsibilities:
- Align closely with global and local business partners to drive quality oversight and governance of patientfocused activities involving Patient Safety, Pharmacovigilance, Device Vigilance, Ethical, Regulatory, and Reputational issues covering all global and local country Novartis Enterprises.
- Drive quality leadership, oversight, and governance of PV activities within and outside of Development and CMO. Ensure compliance with PV regulatory requirements and establish harmonized internal standards for global, regional, and local commercially oriented patientfocused activities.
- Ensure a high level of HA PV inspection readiness at the global and local level. Work closely with applicable business partners on preparation, management, facilitation, and followup for PV inspections, as well as for Clinical, GMP, and Device inspections with PV components. Drive the development of robust and sustainable inspection responses and corrective and preventive action plans.
- Contribute to fulfilment of NVS strategic objectives through support of Merger & Acquisition activities, including performance of Due Diligence and leading/managing PV/QMS transitions, integrations, and divestments.
- Maintain oversight of the structures, processes, and performance metrics of the Novartis Enterprise PV/DV quality system and support ongoing updates of the Novartis PV System Master File (PSMF) to ensure timely release of updates that are in compliance with regulatory requirements, internal standards, and the protection of patients for the Novartis product portfolio and covering the full product life cycle.
- Ensure effective quality oversight, management, and support of global PV operational vendors. Drive vendor quality awareness and improvement measures.
- Serve as the Safety Quality representative on the Portfolio Stewardship Board (PSB), responsible for preventing, mitigating, and/or minimizing potential safety risks for patients, and reducing the risk of litigation and reputation damage to the company in relation to safety issues that cannot be solved at the level of the line function unit or other safety boards.
- Contribute to the quality management cycle including working with business partners to identify quality improvement opportunities and incorporate them into the annual Quality Plan.
- Drive quality performance of the Novartis PV and Device Vigilance Systems to ensure tasks and responsibilities required under global PV and Device Vigilance regulations are fulfilled regarding monitoring the safety of Novartisauthorized products and detecting changes to their riskbenefit balance.
- Develop appropriate measures to assure communication, management, and remediation of PV/Device Vigilancerelated quality and compliance issues.
Commitment to Diversity & Inclusion:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Role Requirements
Essential requirements:
- Education: Degree in Life Sciences or related scientific discipline. PhD or other higher degree desirable.
- At least 10 years of Pharmaceutical industry experience with at least 5 years of PV, Quality Management and/or GXP Regulatory experience demonstrating increasing levels of responsibility.
- At least 3 years global team management experience or equivalent.
- Thorough and extensive knowledge of international PV and DV regulations, including FDA/EU PV, ICH, new drug regulations, other key HA guidance's, and current industry practice.
- Excellent leadership skills, experience managing associates across functional and geographical boundaries, and ability to lead and/or work successfully within crossfunctional teams.
- Capability to drive and implement changes and agility, dynamic with excellent negotiation and communication skills.
- English fluent, written and spoken. Other languages are a plus.
Desirable requirements:
- Prior experience with coordination, facilitation, and management of HA inspections, including preparation of HA inspection CAPAs will be highly valued.
Why Novartis:
Commitment to Diversity and Inclusion:
Novartis is committed to building an outs
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