Why Patients Need You

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

Your strong documentation skills will be an asset for the team. You will help us draft mreports for submission to regulatory agencies or in-company use.

Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve ItCommunicate 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.

QualificationsEducation: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 areasAdvanced 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)

  
Work Set Up- Hybrid

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Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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