Lead and oversee EU QPPV and European Safety Office compliance activities, ensure PV system quality, readiness for inspections and audits, maintain PSMFs and documentation, collaborate with cross-functional and external partners to align pharmacovigilance with regulatory requirements.
Position Purpose
The QPPV Compliance Director supports the activities of European Union Qualified Person for Pharmacovigilance (EUQPPV) and the European Safety Office and guarantees the oversight of the quality and compliance of the Pharmacovigilance system.
Primary Responsibilities
• Establishment of a monitoring system to ensure evolving local requirements are reflected in the local QPPVs activities and in the global PV system
• Collaboration with SQ as regards the establishment and maintenance of PSMFs where required and the support in case of PV inspections of those countries/regions where a QPPV is required
• Collaborates with PV Licensing Team, for all external partnerships (inbound or outbound) for the development, marketing, promotion or distribution of Pfizer medicinal/device products for human, and their alignment with regulatory requirements
• Quality and compliance interface with partner lines and other stakeholders.
• Support to the overall quality system in collaboration with Medical Quality Assurance, Corporate Audits, and Regulatory Compliance.
• WMS Inspection Readiness; support to the preparation for and to the conduct of internal or external audits and regulatory inspections of the PV system and its components globally
• Keep permanently updated on EU Pharmacovigilance regulations and policies. Ensure constant updates as regards ex-EU regulatory requirements in countries/regions where a QPPV is required
• Ensure that policies and procedures are in place and maintained to guarantee quality and timeliness of deliverables
• Support the activities of WMS, as appropriate, including development of relevant processes and practices, with particular reference to European Directives, Guidances and Points to Consider and ex-EU legislation concerning PV requirements and QPPV functions
• Ensure support to the EUQPPV in the monitoring of compliance (time and quality) for expedited individual and aggregated data reporting, of product issues (including recalls), and of overall performance as regards safety in Europe
• Maintain the documentation systems pertaining to the Global QPPV office activities
Technical Skill Requirements
• Solid understanding of pharmacovigilance internal and external environment, including scientific, methodological and regulatory aspects
• Understanding of product development and clinical research
• Demonstrated ability to analyze, frame, and communicate complex issues and their strategic implications for patient safety, including scientific writing and presentation proficiency
• Technical Skill Requirements , including safety knowledge and abilities in the inspections management
• Strong ability in interacting and collaborating in informal networks and virtual teams and at operating in a matrix environment
• Good oral and written communication and presentation skills
• Excellent communication and negotiation skills with internal and external parties
• High skills in time management and organization
Qualifications (i.e., preferred education, experience, attributes)
• PharmD certification or equivalent scientific degrees
• At least 15 years of relevant experience in the pharmaceutical industry in pharmacovigilance or clinical research departments on an international level
• Good understanding of computer technology, and management of relational database systems
• Fluency in written and verbal English
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Medical
The QPPV Compliance Director supports the activities of European Union Qualified Person for Pharmacovigilance (EUQPPV) and the European Safety Office and guarantees the oversight of the quality and compliance of the Pharmacovigilance system.
Primary Responsibilities
• Establishment of a monitoring system to ensure evolving local requirements are reflected in the local QPPVs activities and in the global PV system
• Collaboration with SQ as regards the establishment and maintenance of PSMFs where required and the support in case of PV inspections of those countries/regions where a QPPV is required
• Collaborates with PV Licensing Team, for all external partnerships (inbound or outbound) for the development, marketing, promotion or distribution of Pfizer medicinal/device products for human, and their alignment with regulatory requirements
• Quality and compliance interface with partner lines and other stakeholders.
• Support to the overall quality system in collaboration with Medical Quality Assurance, Corporate Audits, and Regulatory Compliance.
• WMS Inspection Readiness; support to the preparation for and to the conduct of internal or external audits and regulatory inspections of the PV system and its components globally
• Keep permanently updated on EU Pharmacovigilance regulations and policies. Ensure constant updates as regards ex-EU regulatory requirements in countries/regions where a QPPV is required
• Ensure that policies and procedures are in place and maintained to guarantee quality and timeliness of deliverables
• Support the activities of WMS, as appropriate, including development of relevant processes and practices, with particular reference to European Directives, Guidances and Points to Consider and ex-EU legislation concerning PV requirements and QPPV functions
• Ensure support to the EUQPPV in the monitoring of compliance (time and quality) for expedited individual and aggregated data reporting, of product issues (including recalls), and of overall performance as regards safety in Europe
• Maintain the documentation systems pertaining to the Global QPPV office activities
Technical Skill Requirements
• Solid understanding of pharmacovigilance internal and external environment, including scientific, methodological and regulatory aspects
• Understanding of product development and clinical research
• Demonstrated ability to analyze, frame, and communicate complex issues and their strategic implications for patient safety, including scientific writing and presentation proficiency
• Technical Skill Requirements , including safety knowledge and abilities in the inspections management
• Strong ability in interacting and collaborating in informal networks and virtual teams and at operating in a matrix environment
• Good oral and written communication and presentation skills
• Excellent communication and negotiation skills with internal and external parties
• High skills in time management and organization
Qualifications (i.e., preferred education, experience, attributes)
• PharmD certification or equivalent scientific degrees
• At least 15 years of relevant experience in the pharmaceutical industry in pharmacovigilance or clinical research departments on an international level
• Good understanding of computer technology, and management of relational database systems
• Fluency in written and verbal English
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Medical
Top Skills
Relational Database Systems
What you need to know about the Edinburgh Tech Scene
From traditional pubs and centuries-old universities to sleek shopping malls and glass-paneled office buildings, Edinburgh's architecture reflects its unique blend of history and modernity. But the fusion of past and future isn't just visible in its buildings; it's also shaping the city's economy. Named the United Kingdom's leading technology ecosystem outside of London, Edinburgh plays host to major global companies like Apple and Adobe, as well as a growing number of innovative startups in fields like cybersecurity, finance and healthcare.
