Compliance Analytics, Senior Manager

Use Your Power for Purpose

Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.

Position Purpose

• Develop and evolve strategies for operationalizing metrics and processes to enable effective oversight of safety and regulatory quality and compliance.  Serves as Document Quality and Compliance (DQC) point of contact and Subject Matter Expert (SME) for quality oversight and compliance topics.

• In collaboration with Head of DQC:

  o   Provides strategic leadership and oversight for DQC delivery of services, policies and work across WWS targets and stakeholders. 

  o   Promotes cross-group consistency, standards, and strategies for DQC across global safety and other partners.

  o   Fosters harmonization across sites, customers and processes for the integrated delivery of DQC services; champions, maintains and instills a global perspective with a focus on strategy, promoting quality oversight and Right First Time initiatives.

• Ensure a global understanding of the vision of DQC and its connection to WWS in support of Business Units and other Partner Lines; fosters effective relationships with key internal/external customers and stakeholders.

Key Responsibilities

• Significantly contributes to the development and implementation of strategies for compliance/performance and process analytics, information delivery and corrective action implementation across the portfolio with potential focus on Lightspeed and/or high risk/high profile products.

• Generates integrated compliance data relative to areas of delays, trending of data, root cause analysis and corrective/preventative action planning for aggregate reports, risk management and signal detection areas.

• Liaises with Supplying Organizations (SOs) and other key external customer groups in support of proactive management of compliance and promotion of corrective action planning activities.

• Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analysis, and corrective action planning.

• Ensures linkages with Supplying Country Organizations (SCOs), US Supplying Organizations, EU QP Office and Drug Safety Unit (DSU) management in proactively facilitating compliance and corrective action planning in support of continuous improvement 

• Provides linkages between therapeutic areas and internal and external customers (e.g. PCOs, PGM) relative to compliance support activities.

• Provides input on quality services and policies working with Directors, Senior Directors and Governance committees.

• Actively participates in strategy decisions related to global quality technology and utilizes technology to increase efficiency and better ensure quality outputs.

• Focuses quality services by working with other functional lines and sites, better ensuring that deliverables for the processes and products are met, along with safety needs.

• Maintains current knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission and electronic reporting requirements, and other relevant regulations and guidance. 

• Mentors and coaches key SQ DQC staff as identified by succession plans.

• Travels to other Pfizer sites as required.

Qualifications
 

Education

• Bachelor's degree (or equivalent) required, scientific field preferred

• An Advanced degree is preferred

• Healthcare professional is desired

Experience

• Minimum 5 - 7 years of experience in Pharmacovigilance, Regulatory Affairs, or within a Health Authority.

• Extensive clinical development and/or post-marketing and business experience to have a thorough understanding of the processes associated with clinical, safety or regulatory operations. 

• Extensive experience with complex analytics and systems, including interpretation and utilization of data to drive continuous improvement and measure effectiveness of processes.

• Leadership, project management, resource management, administrative, and strong technical capabilities are required. 

• Effective verbal and written communication skills in rela