Job Description

Position Purpose
+ The PSSR Aggregate Reports 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, Risk Management Plans and relevant documents, and other documents in support ofsafety changes to labeling documents.
+ Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission.Provide project teams with expertise and strategic guidance on analysis and presentation of safety data and on 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.
+ Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a particular project.
+ Support WSR teams by providing analyses of post-marketing safety data, reviews of the medical literature, and similar related activities.
Primary Responsibilities
+ Communicate SER'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 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 SER '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.
Technical Skill Requirements
+ Writing skills.Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
+ Analytic skills.Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
+ Oral presentation skills.Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences
+ Language skills.High fluency in written English and strong functional fluency in spoken English.Knowledge of additional languages is an asset.
+ Personal skills.Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
+ Interpersonal skills. Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy.Ability to work well with all levels and roles in cross-functional, global teams.Ability to mentor more junior colleagues and external vendors.
+ Regulatory knowledge.Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data.
+ Software. Previous experience with software commonly used to present and analyze data (Word, Power