Organizational Relationship(s) including to whom the position reports (JD Job Title):

Reports to Head of ICSR Quality and Compliance or Team Lead.

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

Senior Associate

• 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 computer skills desired.
• Strong commitment to quality.

Hybrid Set Up

#LI-PFE

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