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 systemCollaboration 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 requiredCollaborates 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 requirementsQuality 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 globallyKeep permanently updated on EU Pharmacovigilance regulations and policies. Ensure constant updates as regards ex-EU regulatory requirements in countries/regions where a QPPV is requiredEnsure that policies and procedures are in place and maintained to guarantee quality and timeliness of deliverablesSupport 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 functionsEnsure 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 EuropeMaintain 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 aspectsUnderstanding of product development and clinical researchDemonstrated ability to analyze, frame, and communicate complex issues and their strategic implications for patient safety, including scientific writing and presentation proficiencyTechnical Skill Requirements, including safety knowledge and abilities in the inspections managementStrong ability in interacting and collaborating in informal networks and virtual teams and at operating in a matrix environmentGood oral and written communication and presentation skillsExcellent communication and negotiation skills with internal and external partiesHigh skills in time management and organization
Qualifications (i.e., Preferred Education, Experience, Attributes)
PharmD certification or equivalent scientific degreesAt least 15 years of relevant experience in the pharmaceutical industry in pharmacovigilance or clinical research departments on an international levelGood understanding of computer technology, and management of relational database systemsFluency in written and verbal English
Work Location HybridPurposeBreakthroughs 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 StrategyOne 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.FlexibilityWe 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 OpportunityWe 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 InclusionOur 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!#J-18808-Ljbffr