Aggregate Report Analyst Manager

Position Purpose The PSSR Aggregate Report Analyst creates documents pertaining to post-marketing safety data to support product development license application and post-marketing maintenance on behalf of and in conjunction with corresponding project teams 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 New Drug Application Periodic Adverse Drug Experience Reports Safety Update Reports Canadian Annual Reports etc responses to regulatory queries on safety topics post-marketing safety assessments and Risk Management Plans and relevant documents Accurately translate understanding of regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents Assess document requirements gauge document complexity and identify information gaps or other potential issues In collaboration with the relevant project team the author proposes or contributes to strategies to resolve any identified issues Provide oversight for internal or external contractor co-authors when required for a particular project or assignment e g Canadian Annual Report Primary Responsibility Communicate WWS s position on resource and timeline needs for assigned documents to project team members negotiating as needed with the team on these matters and keeping line management informed Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance alerting project teams and line management in a timely manner of any definite or potential deviations Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts Ensure clear factual effective and appropriately concise presentation of analyses and associated discussions in assigned documents Deliver assigned documents on or before deadline alerting project teams and line management in a timely manner of any anticipated delays information gaps or potential shortcomings in quality If overseeing the work of or leading a team of other authors internal or external be accountable for timely delivery of high-quality fit-for-purpose documents to the project team Produce documents in conjunction with external vendors Review documents produced by vendors and help evaluate vendor performance Understand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs DSURs PBRERs and ACOs Collaborate with quality lines and relevant project team subject matter experts ensuring the accuracy and quality of information presented in assigned documents Develop and sustain constructive relationships within other Pfizer lines including country organizations If assigned by manager serve as the WWS point of contact for all document issues for a given product or set of products Identify potential areas for process improvements and possible solutions and communicate these to line management or appropriate functional line Education Bachelor s Degree in life sciences and 3 years relevant medical experience such as patient care clinical trial experience investigator academic medicine specialty training or pharmaceutical industry experience ideally in safety regulatory or clinical areas Advanced degree preferred MD DVM PharmD or Master s PhD in relevant field Experience and Attributes Able to execute routine analyses and interpret routine safety analyses with guidance from team members analytic skills Has comprehensive understanding of regulatory guidance as it pertains to presentation and communication of benefit risk and pharmacovigilance regulatory knowledge Is able to synthesize analyses of aggregate or individual patient data into clearly written text with minimal supervision writing skills Has good understanding of medical concepts of the disease and the specific approach to treatment Makes decisions that require choosing between multiple options to resolve moderately complex problems some of which deviate from standard situations analytic skills and maybe interpersonal skills as well Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates Medical