Position Purpose
The PSSR Aggregate Report Analyst, Manager 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.
In this role you will:
- 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 Responsibilities
- 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.
Technical Skill Requirements
- 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, PowerPoint, Excel) is preferred.
- Statistics. Proficiency with statistical concepts and ability to carry out statistical analyses is desirable.
- Epidemiology. Extensive familiarity with epidemiologic principles and concepts is desirable.
Qualifications (i.e., preferred education, experience, attributes)
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
- e 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
- /PhD in relevant field)
Experience and Attributes:
- Able to execute routine analyses and interpret routinpharmacovigilance (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.
