Head Aggregate Report, Quality Control & Review

Pfizer • New York City, NY

3d • Hybrid

About The Position

The primary objective of the Head of Center of Excellence Aggregate Reporting is to contribute to the surveillance of the safety profiles of Pfizer products, both under development and marketed, for all therapeutic areas, by ensuring efficient and compliant aggregate reporting operations and submissions. The Head of Center of Excellence Aggregate Reporting ensures full alignment of the cross-functional aggregate reporting teams with TA led aggregate reporting teams. The role is responsible for setting aggregate reporting standards, priorities and metrics and defining quality measures for WWS deliverables and executing against these measures to ensure accuracy, internal consistency, and compliance with regulatory expectations. The Head of Center of Excellence Aggregate Reporting has management responsibility for all members of the cross functional aggregate reporting teams, wherever they may be sited (global virtual team management). This is an above country, global function. Cross-functional case processing teams will be in aggregate more than 150 employees. The Head of Center of Excellence Aggregate Reporting provides the strategic direction and oversight of processes, colleagues and vendors/contractors responsible for the preparation of regulatory documents and quality of safety deliverable. The role develops strategies for operationalizing quality/compliance metrics and measurements, trending of quality/compliance metrics, and incorporation of technology and tools in support of continuous quality improvement. These documents include but are not limited to integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, NDA Periodic Adverse Drug Experience Reports, etc.), responses to regulatory questions, post-marketing safety assessment, Clinical Overviews, Risk Management Plans and REMS, documents in support of content of the CDS and other labels. Delivery of some of these documents may be by matrix management of, or collaboration with, other analysts, epidemiologists, physicians and authors in Worldwide Safety or Worldwide Development.

Requirements

• Ability to make independent clinical assessments, based on professional and scientific responsibilities to patients, prescribers, regulators, and providers
• Comprehensive knowledge of current regulations governing the processing and reporting of safety data.
• Excellent ability and extensive experience to interact with Regulators during inspections.
• Hands-on understanding of the use of safety databases for AR purposes.
• Leadership skills appropriate for managing a large multidisciplinary team
• Maintaining highest levels of compliance with international reporting obligations.
• Expertise in root-cause analysis and failure remediation of complaint transactions.
• Proven expertise in large volume AR transactional processing.
• In depth knowledge of authoring principles and aggregate reporting requirements.
• Ability to take complex regulations and interpret them into business requirements for documents to be delivered to health authorities.
• Demonstrated proficiency with computer applications and understanding of safety data.
• Ability to consolidate, analyze and interpret data from multiple data sources.
• Knowledge of global safety database.
• Knowledge of pharmaceutical business, including drug development and regulatory aspects.
• Scientific/medical academic background (eg MD/PharmD/PhD or MSc/BSc with clinical training/experience), or equivalent.
• At least a BS degree in related scientific discipline and 12+ years of work experience with Pharmacovigilance and/or clinical training/experience, Masters and 10+ years of work experience of PHD and 7+ years of work experience.
• Health care professional with a minimum of 2 years of clinical or related experience.
• Minimum 6 years’ experience in large volume aggregate report processing.
• Experience in Quality Control and Quality Assurance within the pharmaceutical industry.
• Experience in successfully managing health authority audits.
• Experience in optimizing transactional operations with a respective track record (e.g. significant improvement in processing efficiency, significant improvements in reporting compliance.
• Knowledge of US and international regulatory/safety regulations and guidelines.
• Experience working with the safety databases.
• Track record of communicating complex information and analyses effectively in writing to a variety of scientific and non-scientific audiences.
• Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
• Extensive experience in Safety, Regulatory or Clinical Development and business experience.
• Proven experience in a project management role, leading a team or function.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
• Permanent work authorization in the United States.

Nice To Haves

• Occasional travel required to other sites

Responsibilities

• Establish the goals, and manage the day-to-day performance, of the multi-functional team responsible for cross-functional efficient and compliant generation of aggregate reports (AR) and responses to regulatory questions, post-marketing safety assessment, Clinical Overviews, Risk Management Plans and REMS, documents in support of content of the CDS and other labels.
• Defines quality measures for WWS deliverables (aggregate reports, RMPs, REMS,, CDS and other labeling documents, ad hoc safety reports and labeling justifications, integrated analyses such as written summaries of clinical safety, efficacy and pharmacology of the CTD and briefing documents and execute against these measures to ensure the highest level of accuracy, internal consistency, uniformity and compliance with regulatory expectations.
• Responsible for the evaluation of the aggregate reporting portion of acquisitions, divestitures and in-license deals.
• Develops quality metrics and evaluates trends which can be utilized to set strategy and to be shared with the WWS management for continuous improvement purposes.
• Responsible for the quality and timely generation of all AR deliverables and quality of safety deliverables.
• Direct AR generation activities, in accordance with regulations and Pfizer Standard Operating Procedures and associated documents, using assigned resources to meet compliance requirements and performance targets for quality and timeliness.
• Responsible for identifying and driving process improvement/continuous improvement around areas of direct responsibility.
• Participates in appropriate committees including PSSR leadership team, WWS policy committee.
• Facilitate effective communication within the team, with other Safety colleagues and with internal and external stakeholders, to assure that all issues are effectively surfaced for resolution.
• Represent AR for all areas of responsibility for depositions and other legal interaction.
• Provide professional leadership and support to AR team leads and teams as well as AR teams within the PSSR Therapeutic Areas.
• Responsible for transaction-operational standards of own (cross-functional) as well as PSSR TA based AR teams.
• Ensure alignment of all PSSR AR operations.
• Collaborate with appropriate SSRM counterparts to provide strategic direction to the overall benefit/risk profile of a product as well as the strategic direction for rapid response queries to defend, maintain or achieve approval of a product or indication.
• Ensure supervision, management and development of AR staff to meet business requirements consistent with Pfizer Global Performance Management expectations.
• Lead in the design, development and implementation of state of the art processes and training for document preparation where necessary.
• Interact with regulators regarding inspection responses and process expectations.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive