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The applicant will work with teams in multiple therapeutic areas and will be the lead RWD statistician responsible for delivery of these projects. &nbsp;The emphasis will be on analysis of RWD. The applicant is expected to develop effective collaborations with relevant stakeholders including Medical Evidence Generation (MEG) platform leads, and scientists, health economics and outcomes research (HEOR) leads, clinicians, other statisticians, and statistical programmers regarding RWD analysis and strategy.Responsibility extends to methodological research to improve the design, conduct, analysis, and interpretation of the observational studies with focus on causal inference. &nbsp; &nbsp;The successful candidate will:<ul><li>Increase expertise amongst Pfizer statisticians and scientists through dissemination of new RWD analysis and modern analytic methodologies and training on software to implement these approaches.</li><li>Collaborate with development teams by the development and implementation of techniques based on state-of-the-art research.</li><li>Take ownership of projects and liaise with team members as appropriate and may oversee the work of contractors.</li></ul>ROLE RESPONSIBILITIES&nbsp;<ul><li>Provide expert statistical support &nbsp; in the design, analysis, reporting, and interpretation of RWD and in HEOR projects involving observational studies, including those in development supporting drug approval and reimbursement, health technology assessment (HTA), as well as other post-approval activities, in order to inform decision-making and also to guide medical strategy and the scientific narrative through publications and external presentations.</li><li>Partner with MEG leads and scientists, other statisticians, clinical statisticians, HEOR leads, clinicians, statistical programmers, and others to develop and implement an effective plan to leverage RWD.</li><li>Participate in TA specific Real-World Evidence (RWE) regular meetings as needed and engage in proactive communications with project leads to better understand scientific and business needs.</li><li>Provide computational and statistical advice on complex analytic issues supporting Pfizer’s RWD projects and be able to work in an autonomous manner.&nbsp;</li><li>Strong programming skills in SAS with an emphasis on analysis and reporting of RWD to generate RWE. &nbsp;&nbsp;</li><li>Develop, implement, and promote methodologies based on state-of-the-science computing and statistical research and dissemination of the results both internally and externally.</li><li>Provide a strong presence for Pfizer with HTA, regulatory and professional organizations to influence knowledge generation and content of regulatory guidelines to support the adaption of RWE.</li><li>Develop effective collaborations with relevant non-statistical researchers.&nbsp;</li><li>Stay current with research on RWD and observational data methodology and its applications pertinent to the Pfizer business needs.</li><li>Be up-to-date on training and compliance with all Pfizer SOPs as required based on the assigned curriculum.&nbsp;</li></ul>&nbsp; BASIC QUALIFICATIONS:&nbsp;<ul><li>M.S. in Biostatistics or related field with 5+ years of experience in RWD and observational studies, or Ph.D. with 2+ years of relevant experience. Candidates with less work experience, or experience in other fields, will also be considered if they have exceptional methodology research credentials and potential.</li><li>Excellent oral and written communication skills in English language</li></ul>PREFERRED QUALIFICATIONS:<ul><li>Experience with advanced inferential statistics (including and not limited to longitudinal data analysis, missing data methods, multiple comparisons techniques, cost-effectiveness analysis, generalized linear models, meta-analysis), causal inference and real-world data analysis and modern analytic methods such as propensity scores, regularized generalized linear models, AI/ML methods and related techniques to analyze RWD</li><li>Demonstrated understanding of RWD and observational study design and analysis to assess confounding and other related bias with RWD studies</li><li>Familiarity with drug development processes</li><li>Proficient with subject matter content in at least one therapeutic area like oncology or inflammation, internal medicine etc.</li><li>Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization</li><li>Broad-based understanding of statistical theory and its application&nbsp;</li></ul>Please apply by sending your CV and a motivational letter in English

Sr. Manager, Statistics (RWE) Athens 

Sr. Manager, Statistics (RWE)

Within Pfizer Digital, the Customer &amp; Commercial Creation Center (C4) group builds solutions for external customers throughout the product lifecycle​. We support stakeholders to engage external ​customers through digital solutions, whether that is patients, HCPs, payors, pharmacists, or clinical sites.The Customer &amp; Commercial Creation Center (C4) are thought partners and technical solution providers to commercial arms of the business (e.g., Pfizer’s ​sales force or marketers), working at the intersection of technology and healthcare.Our Salesforce.com Platform DevSecOps &amp; Engineering team focuses on Salesforce.com and surrounding enabling technologies as a strategic platform for Pfizer customer facing Colleagues, relationship management, and various business workflow or lifecycle applications.&nbsp; We are an enterprise facing team that drives to provide the best DevSecOps, security, standards, and quality assurance processes and tooling that we can achieve for the organizations we serve, namely the production support/ops teams as well as solution delivery teams in various functional disciplines.Our vision is to innovate and engineer breakthrough digital products to power business performance and transform global health. We do this through our culture of agile, fast-adapting and pioneer working.What You Will AchieveWe are seeking a highly skilled and experienced Principal Engineer who will be accountable for technical engineering decisions, solution designs, and delivery, as well as operations of their assigned program.In this technical leadership role, you will act as the executor and the visionary behind technical solutions. You will lead teams of between 10 and 25 technical resources to solve complex engineering problems, craft the technical designs and ensure a successful delivery of high-quality products and services from inception to completion. This role requires exceptional technical knowledge, strong management skills, and the ability to collaborate effectively with cross-functional teams while sharing responsibility with the other program leads for achieving the desired objectives.You will also be accountable for delivery of security-and privacy-first capabilities while creating an environment where engineers can do their best work as measured by a quarterly Developer’s Experience survey, and alignment and contribution to the service network and technical engineering standards.Key Responsibilities:<ul><li>A normal work week consists of leading one or more teams of engineers to deliver and implement technical solutions, following your design approach to meet your assigned program objectives and KPIs. You will also collaborate closely and often with your program Chief Marketing Office Lead, Digital Lead, and Product Owners, to ensure that technical decisions and their implementation align with broader strategic priorities.</li><li>You represent engineering in program and stakeholder meetings, as such you’ll need to be able to think on your feet: provide consultation, identify risks based on a variety of factors, and rely on your past experiences to identify potential solutions and develop ballpark estimates.</li><li>In many situations you will be working with technology that is new to Pfizer and requires you to learn quickly, be able to read and understand documentation, and architect robust and scalable solutions that align with our business objectives.</li><li>Using influence more than authority, you will lead teams of engineers on the implementation of the solution. Individual members of the team are responsible for delivering on their commitments, but the team supports each other. The team pride themselves on the quality of their code, our delivery practices and breadth of our test coverage. You will be expected to document your work.</li></ul>Technical Leadership<ul><li>Serve as the top technical authority on projects, making decisions on technology choices, design approaches, solution architecture and implementation.</li><li>Lead and oversee the entire lifecycle excellence of engineering projects, ensuring alignment with architectural vision and adherence to best practices.</li><li>Responsible for maintaining good code quality by promoting and ensuring secure code hygiene</li><li>Responsible for guiding the correct configuration of SaaS solutions to ensure security and compliance</li><li>Build a teamable to manage change. Take appropriate risks to achieve the desired results, balancing risks to stability and current norms versus the need for constant change, improvement, and simplification.</li><li>Facilitate the conversation between Enterprise Architects, Business Architects, Vendors and Developers, by providing technical clarity on solution(s) to build and code to write, move content from ideation into delivery to move from concept to reality.</li></ul>Cross-Team Collaboration<ul><li>Act as a translator between business stakeholders and technical engineers, to ensure that technical, security and privacy considerations are represented in strategic discussions and business objectives are being met by our solutions.</li><li>Align objectives, dependencies, and schedules across multiple teams to keep teams unblocked, and to ensure seamless projects execution.</li><li>Collaborate with other Principal Engineers, and through the Principal Engineers Forum, to share best practices, quality standards, address improvement areas, and ensure&nbsp;effective communication of&nbsp;information.</li><li>Collaborate with security teams to monitor vulnerabilities, implement defenses, and ensure compliance with security best practices.</li><li>Collaborate with digital operations and support to ensure smooth BAU operations.</li></ul>Excellence by Design<ul><li>Continuously discover, define, architect, deliver, and enable solutions that support program OKRs.</li><li>Offer deep technical expertise, providing insights and guidance, ensuring solutions are secure, compliant, scalable, maintainable, and efficient.</li><li>Advocate for the adoption of best practices, new technologies, automation, and continuous improvement initiatives in both technical and privacy domains.</li><li>Foster a DevOps model of success by building a culture of shared responsibilities and transparency leading to higher quality and quicker delivery of outcomes.</li><li>Stay updated on emerging technologies, industry trends, and best practices, and apply this knowledge to improve engineering processes and drive innovation within the organization.</li><li>Ensure that privacy and security are an integral part of the system design, not merely layered on.</li></ul>Coaching &amp; Mentorship<ul><li>Participate in or lead code reviews, where applicable.</li><li>Provide technical guidance and mentorship to junior and mid-level engineers, facilitate knowledge sharing and taking an active role in supporting the development of the wider team and their careers. Foster a culture of excellence, innovation, and continuous learning within the engineering team.</li><li>Act on Developer Experience (DX) survey findings and feedback from the engineering team members, to drive&nbsp;continuous improvement initiatives to increase the “Ease of Delivery” of the team.</li></ul>Incident Management &amp; Recovery<ul><li>Lead or assist in the response to security incidents, ensuring rapid containment, mitigation, and recovery.</li><li>Lead troubleshooting during operational outages, guiding the team to diagnose and resolve issues quickly.</li><li>Work towards system resilience and implement post-mortem analyses to identify root causes and prevent future incidents.</li><li>Ensure that solutions are designed with data privacy considerations from the outset.</li></ul>Required Skills &amp; Knowledge<ul><li>Extensive experience in software engineering, with a focus on leading complex projects.</li><li>Deep technical expertise from a well-documented background as a senior-level engineer.</li><li>Strong problem-solving and analytical abilities, with a keen attention to detail.</li><li>A broad technical knowledge of digital pharmaceutical sciences platforms and best practices across both user interfaces and back-end systems, as a “jack of all trades”.</li><li>Proven technical leadership skills, mentorship, with the ability to motivate and inspire team members and fellow engineers towards achieving common goals.</li><li>Exceptional interpersonal skills, with the ability to communicate effectively in a matrix environment with geographically distributed resources, and establish strong partnerships with senior non-technical stakeholders, with a talent to explain complex topics simply.</li><li>Ability to influence and work with cross-functional teams to deliver complex projects in accordance with broader strategies.</li><li>Deep understanding of software development methodologies and best practices for implementing principles of privacy &amp; security ‘by design’.</li><li>Understanding of the implications, regulations, and best practices of data handling in the pharmaceutical industry.</li><li>Understanding of the DevSecOps best practices that should be in place, driving an “Everything as Code instead of paperwork” mentality.</li><li>Familiarity with the multiple policies, standards, systems, and organizations within the pharmaceutical industry, to minimize risk of challenges or duplication in implementation.</li></ul>Here Is What You Need (Minimum Requirements)<ul><li>Bachelor’s in Computer Science, Engineering, or a related field with 8 years’ experience with increasing responsibility delivering digital solutions, products, and services or Master’s degree and 7+ years of experience .</li><li>Professional certifications in engineering leadership are a plus.</li><li>Demonstrable experience operating in a DevOps environment.</li><li>Proven capability handling large scale, enterprise software delivery in a global 24/7 environment.</li><li>Demonstrated hands-on experience using Salesforce.com, Data Cloud, AgentForce, and TableauNext Semantic Layer in particular to build real-life large-scaled solutions.</li><li>Salesforce Data Cloud experience a must</li><li>Agentforce and TableauNext experience a plus</li><li>Copado and SonarQube experience preferred</li><li>Experience with Atlassian (Jira/Confluence)</li><li>Experience driving and participating in technical discovery to architect and deliver solutions that meet program business objectives.</li><li>Systems thinking experience demonstrated by architecting complex solutions that require integrating multiple solutions.</li><li>Experience with multi-cloud architecture and deployments</li><li>Experience working with remote teams and multi-cultural teams</li><li>Experience in highly regulated and sensitive data handling scenarios preferred</li><li>Experience with security and compliance audit processes preferred</li><li>Understanding of CI/CD practices, RESTful APIs, integration patterns, microservice patterns and other areas of interest to modern software development.</li><li>Excellent experience with Agile team processes, including Scrum and Kanban delivery - we enjoy working with lean methods.</li><li>Excellent experience estimating complex technical stories and breaking them down.</li><li>Strong written and spoken English with excellent asynchronous collaboration and communication.</li></ul> 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.

Director - Principal Engineer - Data Cloud

Pfizer is hiring a European Safety Office Medical Senior Manager to support the Pfizer pharmacovigilance system and the adequate surveillance of the safety profiles of Pfizer products of European (all European Union Member States and the three EFTA countries Iceland, Liechtenstein and Norway) interest, both marketed and under development with intent to register (registration-targeted clinical activities started), for one or more therapeutic areas; to report and interact on these safety profiles with the European Drug Agencies; and to provide advice for Europe-related purposes, such as regulatory actions and documents, product labeling, risk management, safety data exchange agreements, and clinical trial programs.Primary Responsibilities<ul><li>Keep permanently updated on EU Pharmacovigilance regulations and policies.</li><li>Ensure support the EUQPPV and Deputy in fulfilling safety qualified person obligations in Europe.</li><li>Support the activities of WMS, as appropriate, including development of relevant processes and practices, with particular reference to European Directives, Guidance and Points to Consider.</li><li>Ensure support to the EUQPPV in the monitoring of compliance (time and quality) for expedited individual and aggregated data reporting, of product issues (including recalls), and of overall performance as regards safety in Europe.</li><li>Partner with relevant functions to ensure the monitoring of cumulative safety data for products approved in Europe as well as products in development with intent to register, and to support safety signal generation and evaluation activities, in one or more specific therapeutic area(s) of responsibility.</li><li>Participate directly or via a designee to Risk Management Committees and benefit/risk governance bodies as required.</li><li>Partner with relevant functions to support and ensure the appropriate and timely delivery of high quality aggregated data reports and other regulatory documents for European Health Authorities, in compliance with European requirements, for all products within the therapeutic area(s) of responsibility. </li><li>Ensure the timely and quality review of aggregate data reports, safety data exchange agreements, labelling (Core Data Sheet and, for CAP and MRP products, SmPC), pharmacovigilance and risk management plans, and other documents (e.g. protocols for post-authorisation safety studies, study reports). </li><li>Partner with relevant functions to support the definition and update of product safety profiles and labelling in Europe. </li><li>Support the functions responsible for submission of individual reports to the EudraVigilance database. </li><li>Globally monitor all safety related matters potentially impacting on Europe. </li><li>Collaborate with the safety functions within WMS, as well as other departments, as appropriate, to ensure effective collaboration on all European issues. </li><li>Represent PFE at drug agencies in Europe where required. </li><li>Support the PFE country-based safety units as regards pharmacovigilance aspects of European relevance.</li><li>Support the monitoring of the status of PFE products in Europe, including commitments, and the monitoring of the evolution of the European regulatory/methodological/ philosophical approaches to drug safety. </li><li>Maintain the documentation systems pertaining to the EUQPPV activities. </li><li>Selection of adequate personnel, and their training in pharmacovigilance and relevant processes and procedures.</li><li>Ensure that each role in the function has an adequate job description. </li><li>Ensure that policies and procedures are in place and maintained to guarantee quality and timeliness of deliverables.</li></ul>Qualifications<ul><li>Medically qualified (MD certification or equivalent). Higher medical degree or specialization, experience in clinical research preferred, experience in epidemiology preferred.</li><li>Sound medical knowledge.</li><li>Previous experience in the pharmaceutical industry in pharmacovigilance or clinical research departments on an international level.</li><li>Good understanding of computer technology, and management of relational database systems.</li><li>Fluency in written and verbal English. Working knowledge of at least one other European language preferred.</li></ul>Technical Skill Requirements<ul><li>Expertise in medical aspects of pharmacovigilance, scientific basis for therapies and drug-induced diseases.</li><li>Understanding of pharmacovigilance internal and external environment, including scientific, methodological and regulatory aspects with a special focus on European requirements.</li><li>Understanding of product development and clinical research.</li><li>Demonstrated ability to analyze, frame, and communicate complex issues and their strategic implications for patient safety, including scientific writing and presentation proficiency.</li><li>Ability at operating in a matrix environment.</li><li>Good oral and written communication and presentation skills.</li><li>Good communication and negotiation skills with internal and external parties.</li><li>High skills in time management and organization.</li></ul>Purpose&nbsp;Breakthroughs that change patients' lives... At Pfizer we are a&nbsp;patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.&nbsp;&nbsp;Digital Transformation StrategyOne bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.Flexibility&nbsp;&nbsp;We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.&nbsp;Let’s start the conversation!&nbsp;&nbsp;Equal Employment Opportunity&nbsp;We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.Disability Inclusion Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!Pursuant to Article 24(6) of the Act of June 24, 2024 on the protection of whistleblowers, Pfizer Polska Sp. z o.o. and Pfizer Trading Polska Sp. z o.o. declare that they have adopted a joint internal reporting procedure, which, in accordance with the provisions of the aforementioned Act, is also available to persons applying for employment on the basis of an employment relationship or other legal relationship constituting the basis for providing work or services or performing functions. The content of the procedure is made available upon request sent to the contact person or to the email address sygnalisci-px@pfizer.com.

European Safety Office (ESO) Medical Senior Manager

The Associate Medical Director perform the medical assessment activities related to drug safety pharmacovigilance for the assigned therapeutic area(s). The Associate Medical Director proactively evaluates safety information from individual cases and cumulative data, identifies and analyses potential signals, and communicates data-driven conclusions to internal and external stakeholders.The Associate Medical Director Reports to Therapeutic Area Head or to Medical Director.What You Will AchieveIn this role, you will:<ul><li>Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding</li><li>conventions.</li><li>Maintain the timely submission of expedited reports.</li><li>Support the achievement of the Therapeutic Area’s case processing performance timelines. Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.</li><li>Identify and evaluate safety signals based on individual cases and cumulative data assessment and by using other signal detection systems. Provide data-driven decisions and communicate these findings proactively and effectively to the key stakeholders.</li><li>Partner with Safety Surveillance and Risk Management and with other Worldwide Safety and Regulatory functional groups to monitor the safety profile of assigned products.</li><li>Actively participate in Risk Management Committees and other risk management activities for assigned therapeutic areas. Perform product safety reviews as appropriate.</li><li>Provide medical safety input as appropriate to Clinical Development Teams regarding expectedness/listedness/labeledness, causality, and data reconciliation.</li><li>As appropriate, provide medical safety input, and review or draft sections of response documents to health authority inquiries.</li><li>Work with the Therapeutic Area Head and Medical Review Head to proactively and effectively communicate product safety issues and proposed solutions to PSSR management and to the Office of the EU Qualified Person.</li><li>Provide timely review of and input to documents, including labeling, protocols, Investigator Brochure, and licensing agreements.</li><li>Provide timely input into product related milestones.</li><li>Provide medical input, review and analysis of Periodic Safety Update Reports, Expert Statements, Risk Management Plans, and other aggregate reports; where appropriate, draft components of these reports. Ensure accurate, relevant, and meaningful ICSR data and insights.</li><li>Provide medical advice and insights to Therapeutic Area colleagues to improve the quality, consistency, accuracy, and clinical relevance of safety reports.</li><li>Support PSSR Quality Assurance activities, addressing observations related to medical assessment, as appropriate. Ensure consistency and quality of the medical assessment process.</li><li>Provide drug safety support when appropriate to product acquisitions, recalls, and legal issues.</li><li>Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.</li><li>Proactively communicate with and engage Therapeutic Area colleagues and key stakeholders (e.g., Clinical Development Teams, Regulatory Affairs, Licensing, Manufacturing, and Marketing) to support business objectives and to discuss and resolve safety issues.</li><li>Engage internal and external customers with a sense of urgency and an appreciation of their needs and point of view.</li><li>As an individual contributor, initiate and/or take a leadership role in projects/process improvements that align with PSSR strategic objectives.</li><li>Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio.</li><li>Develop and maintain a comprehensive working knowledge of current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Safety Job Aids, and case processing/coding conventions, consistently completing curriculum training by the specified due dates.</li><li>Utilize the corporate performance management process to manage goal setting and individual development. Consistently demonstrate Pfizer Values and Leader Behaviors.</li><li>Proactively mentor Therapeutic Area colleagues to foster an environment of trust, understanding, learning, and development.</li><li>Manage or contribute to the mentoring and on-boarding of new PSSR colleagues</li></ul>Here Is What You Need Technical Skill Requirements<ul><li>Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the Pfizer Global Safety Database, Argus Safety, and MS Window, Excel, Word and Outlook</li><li>Ability to achieve personal objectives while meeting departmental standards of performance</li><li>Fluency in oral and written English; knowledge of additional language(s) an advantage</li><li>Experience and skill with medical writing an advantage</li></ul>Qualifications <ul><li>Medical Degree from an accredited institution</li><li>One to two years of experience as an MD in clinical practice</li><li>One to two years of relevant experience in pharmacovigilance, clinical research or related field</li><li>Pharmaceutical industry experience preferred</li><li>Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports</li></ul>Please apply by sending your CV and a motivational letter in English

Θέσεις Εργασίας Ελλάδα, Pfizer-hellas

sr. manager, statistics (rwe) athens

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sr. manager, statistics (rwe)

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director - principal engineer - data cloud

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european safety office (eso) medical senior manager

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associate medical director

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