QPPV Compliance Director

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