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

· 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.

· Liaises with key stakeholders in facilitating quality, compliance and corrective action planning in support of continuous improvement across case processing and adverse event (AE) reporting.

· Compiles integrated quality and compliance/performance metrics from ICSR processing.

· Supports quality oversight by performing quality reviews of adherence to ICSR case processing policies and procedures

· Participates in processes for analytics and reporting of integrated compliance and performance information across AE reporting processes and late reports.

· 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.

· 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 computerskills desired.

· Strong commitment to quality.

 
Work Location Assignment: Hybrid

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control

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