Pfizer Head of Pharmacovigilance Quality Oversight in Groton, Connecticut
Develops strategies for operationalizing quality/compliance measurements and information, trending of quality and compliance data, and incorporation of technology and tools in support of quality and compliance oversight, and continuous quality improvement.
Applies risk assessment methods and approaches to identify and track risks to the pharmacovigilance system, and leads initiatives to implement effective risk mitigation strategies.
Designs and develops data analysis solutions and visualizations to measure and monitor quality/compliance and risk mitigations across the pharmacovigilance system.
Draws on internal and external subject-matter expertise to advise and provide guidance to SQ and WMS colleagues on quality and compliance oversight, continuous quality improvement solutions, and process, technical and policy issues.
Provides oversight and support to Quality Event/CAPA Managers and Commitment Leads/Owners and serves as conduit between BPOs, business lines, quality groups and governance groups to enable and promote quality, accountability and effective delivery of CAPAs and Commitments across WMS.
Supports new and ad hoc requests for data analysis and reporting in support of inspection readiness, and inspection response.
Provides strategic and operational leadership for PVQO delivery of services across WMS in collaboration with other SQ Heads and the Head of SQ. Fosters effective relationships with key internal/external customers and stakeholders.
Leads individuals in the PVQO group to implement and execute the quality framework across global WWS processes and deliverables.
Defines strategies and operational plans for quality/compliance data collection, measurement, trending and analysis, together with the identification of corrective and preventative action planning, and incorporation of continuous quality improvement methodologies and tools.
Responsible for the creation and development of reports used to measure and monitor performance (quality and compliance) and risks of pharmacovigilance processes and deliverables to various stakeholders at Functional, Departmenal and Divisional levels.
Lead in-depth analyses and provides recommendations to management and senior leaders in complex, ambiguous situations across WMS, and in support of CAPAs, commitments and inspections.
Assess new requests and propose solutions based on extensive knowledge of quality databases and systems, and applicable guidelines and regulations.
Establish processes for evaluating and developing new requests that provide the most efficient use of resources, available technology, and available data.
Evaluate and manage existing and new technology solutions for data collection, analysis and reporting, and develop strategies for identification and incorporation of new technology and of technology applications.
Lead operational/strategic teams within and across functions and lines to accomplish business objectives.
Participate in strategic planning sessions as a member of the SQ LT.
In conjunction with other SQ Heads and the Head of SQ, fosters harmonization across sites, customers, and processes. Champion, maintain, and instill a global perspective with a focus on strategy, promoting quality oversight, and Right First Time initiatives.
Develop people, including recruitment, engagement, retention, and career development planning for PVQO colleagues and work in concert with other SQ Heads and the Head of SQ to define and implement succession plans.
Liaise with Commercial Quality Oversight (CQO) to ensure quality oversight of CEP/CIT/SL/PM processes under the respective policies. This includes ensuring that processes have controls for proper product safety information reporting and that quality oversight measures are in place (that is, appropriate quality metrics, quality reporting to business units and other stakeholders, oversight of CAPA commitments, and effective quality oversight forums).
Excellent analytical skills with experience generating business metrics.
Thorough understanding of the processes associated with Pharmacovigilance, Safety Reporting, Regulatory or Clinical development.
Extensive knowledge of the pharmaceutical industry, with expertise in Pharmacovigilance and/or regulatory reporting and/or compliance.
Experience managing direct reports.
Demonstrated ability to negotiate with business stakeholders.
Demonstrated ability to manage complex projects and cross-functional processes, and to establish and meet deadlines.
Demonstrated ability to effectively work on simultaneous complex projects/deliverables.
Ability to work effectively and contribute proactively in a team-based environment as well as in partnership with colleagues, customers, and stakeholders.
Effective verbal and written communication skills consistently demonstrated when relating to colleagues and stakeholders both inside and outside the organization.
Knowledge of Safety Reporting systems, and technologies.
Familiarity with tools used for data analysis and visualization.
Experience interacting with Health Authorities (including but not limited to the US FDA, EMA, and MHRA) is preferred.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Masters degree or higher. A scientific or technical degree is preferred.
5 years minimum experience in quality assurance, and/or business analysis, and data visualization.
7-10 years experience in Pharmacovigilance, Regulatory Affairs, Drug Development, or within a Health Authority.
Other Job Details:
Last Date to Apply for Job: December 10th, 2021
Additional Location Information: New York, NY; Collegeville, PA; Peapack, NJ; Groton, CT.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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Quality Assurance and Control