Aggregate Report Management (ARM) Team Lead, Director

Role Summary

The Aggregate Report Management (ARM) Team Lead Director provides the strategic direction and oversight of processes colleagues and vendors/contractors responsible for the preparation of documents pertaining to post-marketing safety data to support product development license application and post-marketing maintenance; and for the management of aggregate reports by matrix management of or in collaboration with corresponding project teams. The aggregate report schedule includes but is not limited to an integrated calendar for 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 Safety Update Reports Canadian Annual Reports etc.) responses to regulatory queries on safety topics post-marketing safety assessments Risk Management Plans and relevant documents The ARM Team Lead Director ensures that the staff within his/her line are appropriately managed such that for the assigned projects high quality documentation compatible with internal and external requirements and regulations are prepared in a timely fashion to support business needs.

Primary Responsibilities

• Lead and manage a team of Aggregate Report Management (ARM) colleagues and/or team leads. Ensure that all staff in their line are well managed and developed to meet business requirements consistent with Pfizer Global Performance Management expectations.
• Ensure the generation and appropriate review of all PSSR aggregate/authoring deliverables assigned to staff within their line.
• Provide oversight and guidance on the development and execution of PSSR document production such that staff may fully undertake their major duties and responsibilities including supervising the overall quality and timeliness of completion of activities assigned to their staff and equipping the team leads in their line to do the same.
• Support and as appropriate actively participate in Risk Management Committees Clinical Teams Labelling Teams and other relevant group or departmental teams.
• Provide strategic direction to the overall alignment of the aggregate reports calendar and regulatory requirements in collaboration with Regulatory Drug Safety Unit (DSU) and/or other key stakeholders. Mentor and guide team leads and other staff within his/her line on strategic considerations in support of compliant aggregate reporting.
• Participate in the design development and implementation of state-of-the art processes and training for document preparation/scheduling where necessary. Contribute to the review and assessment of new aggregate reporting regulatory requirements and contribute to effective implementation within the CoE.
• As appropriate oversee best practices and/or training to ensure compliant document preparation across teams within his/her line.
• Collaborate with Aggregate Report Team Leads Aggregate Report Group Head and Head of Center of Excellence Aggregate Reporting as appropriate to ensure resources within their line are appropriately allocated to projects.
• Collaborate with other members of CoE Aggregate Reporting PSSR and WWS as appropriate to enable effective knowledge transfer communication and workload across global CoE teams. Support and mentor team leads within his/her line to effectively manage knowledge and communication within their teams.
• As needed coordinate inspection readiness activities within his/her line.

Technical Skills Requirements

• Oral presentation skills. Strong oral presentation skills including ability to present explain and defend data analyses before internal and external (including Regulatory Authority) audiences.
• Regulatory knowledge. Familiarity with global regulatory guidance (especially ICH FDA and EMA) relevant to clinical and safety data.
• Software & Systems. Demonstrated proficiency with computer applications (including Microsoft word & Excel Adobe acrobat etc.) and an understanding of safety data. BusinessObjects and SharePoint experience desirable. Knowledge of Document management systems and technologies preferred.
• Specific technical skills. Knowledge of case processing authoring principles and aggregate reporting requirements.

Qualifications

Education

• Bachelors Degree in life sciences and 10 years pharmaceutical industry experience ideally in safety regulatory or clinical medical writing.
• Advanced degree (MD DVM PharmD or Masters/PhD in relevant field) with 6 years pharmaceutical industry experience ideally in safety regulatory or clinical medical writing.

Experience and Attributes

• Scientific/medical academic background ideally with experience in drug development clinical pharmacology and/or pharmacoepidemiology within the pharmaceutical industry regulatory agencies or academia.
• Proven experience in a project management role leading a team or function. Supervisory experience is desirable.
• Experience working with safety databases.
• Acts as a technical/functional expert in the discipline of aggregate reporting providing business direction to key partners.
• Considered a Subject Matter Expert (SME) in aggregate reporting operations.
• Manages leads and oversees resources within CoE Aggregate Reporting focused on business performance and management of high complexity.
• Solves highly complex problems within CoE Aggregate Reporting.
• Decisions impact CoE Aggregate Reporting long-term objectives while broader decisions reviewed by leadership team through results.
• Influences senior management decisions that have impact on business direction.

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.

Work Location Assignment:Hybrid

This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.

Last Day to Apply:

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