Compliance Analytics, Senior Manager

Pfizer; Collegeville (PA); Hybrid; USD 102,000 - 172,000; Full time

Job summary

A leading pharmaceutical company is seeking an experienced professional in quality oversight and compliance to develop strategies for regulatory affairs. This role requires significant expertise in pharmacovigilance and analytics, with strong leadership capabilities. The ideal candidate will have a background in the sciences and a passion for enhancing patient safety through compliance monitoring. The position offers a hybrid working arrangement and competitive salary with comprehensive benefits.

Benefits

401(k) plan with matching contributions

Paid vacation and holidays

Health insurance (medical, dental, vision)

Additional retirement savings contribution

Qualifications

• Minimum 5-7 years of experience in Pharmacovigilance or Regulatory Affairs.
• Strong analytical background and extensive experience with complex data analysis.
• Effective communication skills for interacting with internal and external stakeholders.

Responsibilities

• Develops strategies for operationalizing metrics and oversight.
• Generates compliance data and conducts root cause analysis.
• Liaises with key stakeholders to promote compliance and corrective actions.

Skills

Analytical skills

Leadership

Project management

Communication

Collaboration

Education

Bachelor's degree (scientific field preferred)

Advanced degree preferred

Healthcare professional desired

Tools

Excel

PowerPoint

Word

Job description

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 relating to colleagues and associates both inside and outside the organization.

• Knowledge of organizational development and principles and associated successful implementation desired.

Technical Skill Requirements

• Excellent analytical skills with experience in generating business metrics.
• Demonstrated ability to collaborate effectively with team members and interact at all levels of an organization.
• Demonstrated ability to analyze, evaluate, understand processes quickly, and identify gaps, issues and opportunities for improvement.
• Strong orientation to detail and ability to function independently as appropriate.
• Demonstrates ability to effectively work on simultaneous complex projects/deliverables prioritizing well and recognizing key issues and recommends course of action to management.
• Effective verbal, written and presentation skills consistently demonstrated when relating to colleagues and stakeholders both inside and outside the organization.
• Thorough understanding of system technologies that support the business.
• Proficient with software commonly used to present and analyze data (e.g.Word, PowerPoint, and Excel).

Work Location Assignment:Hybrid

The annual base salary for this position ranges from $102,900.00 to $171,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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. This position requires permanent work authorization in the United States.

Quality Assurance and Control