Pfizer

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.

Position Purpose

• Support the Head of ICSR Quality and Team Lead in the development and implementation of strategies for operationalizing quality checks/QC, metrics and processes to enable effective oversight of safety and regulatory quality and compliance. Serves as ICSRQC point of contact and Subject Matter Expert (SME) for Safety Evaluation & Reporting (SER) and WWS lines on metrics, knowledge sharing, technology, or specific work processes, as appropriate.
• Performs reviews of ICSR quality and compliance data and business processes/procedures to support continuous process improvement and organizational evolution, driving timely measurable and actionable feedback for proactive change.

Primary Responsibilities

Manager

• Compiles integrated quality, compliance and performance metrics across processes for adverse event reports forwarded to Safety Evaluation & Reporting (SER) for processing in accordance with relevant guidelines and internal standards.
• Applies technical skills and specialized knowledge to coordinate initial findings, conduct root cause analysis, and corrective action planning.
• Engages with key stakeholders in facilitating quality, compliance and corrective action planning in support of continuous improvement across case processing and adverse event (AE) reporting.
• Participates in processes for analytics and reporting of integrated compliance and performance information across AE reporting processes and late reports.
• Contributes to development and implementation of strategies for ICSR quality, compliance, performance and process analytics, information delivery and corrective action implementation utilizing technology to increase efficiency and better ensure quality outputs.
• Supports quality oversight by performing quality reviews of adherence to ICSR case processing policies and procedures
• Participates in projects within and across disciplines, taking responsibility for project deliverables.
• Maintains current knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission and electronic reporting requirements, and other relevant regulations and guidances.
• Provides input on quality services and policies working with Head of ICSR Quality and Compliance and/or ICSRQC Director-Team Lead.
• May mentor/coach new staff as required.
• Travels to other sites as required.

Technical Skill Requirements

• Analytical skills with experience in generating business metrics.
• Demonstrates ability to collaborate and contribute effectively with team members and interact at all levels of an organization.
• Demonstrates critical thinking abilities to understand when solving problems and making decisions.
• Demonstrates knowledge of safety and regulatory reporting requirements.
• Demonstrates ability to contribute in complex projects and cross-functional processes to meet established deadlines.
• Demonstrates ability to effectively work on simultaneous complex projects/deliverables
• Thorough understanding of system technologies that support the business.
• Effective verbal, written and presentation skills consistently demonstrated when relating to colleagues and stakeholders both inside and outside the organization.
• Proficient with software commonly used to present and analyze data (Word, PowerPoint, and Excel) required.

Qualifications (i.e., preferred education, experience, attributes)

Education:

Candidates for this job would have a degree in a science or business related discipline and would have the following levels of education:

• Healthcare professional preferred
• BS Degree (or equivalent)
• Advanced degree desired

Experience:

• 3-5 years case processing experience preferred
• Training and/or demonstrated experience in relevant technical and behavioral competencies.
• Clinical development and/or post-marketing and regulatory experience or related discipline.
• Strong verbal, written, communication and presentation skills.
• Innovative and strategic thinking ability.
• Strong computer skills desired.
• Strong commitment to quality.
• Work Location Assignment: On Premise

Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

Quality Assurance and Control

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