Compliance Analytics, Senior Manager
Compliance Analytics, Senior Manager
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$ 102900 - 171500
1 Vacancy
Job Description
Use Your Power for Purpose
Every day Pfizers 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
Bachelors 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 ( PowerPoint and Excel).
Work Location Assignment:Hybrid
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 providers 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.
Required Experience:
Senior Manager
Employment Type
Full-Time
