6 days old

Quality Analyst, ICSR Quality & Compliance

Pfizer
Peapack, New Jersey
**Reports to Head of ICSR Quality and Compliance or Team Lead**



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 guidance.

+ May mentor/coach new staff as required.

+ Travels to other sites as required.



**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 guidance.

+ 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.



**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.



**Other Job Details:**



+ **Last Date to Apply for Job: October 22, 2020**

+ Eligible for Employee Referral Bonus: YES



**\#LI-PFE**



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**EEO & 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, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



Quality Assurance and Control

Categories

Posted: 2020-10-13 Expires: 2020-11-12

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Quality Analyst, ICSR Quality & Compliance

Pfizer
Peapack, New Jersey

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