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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)

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

Associate Medical Director

Job Ads Ελλάδα, Pfizer-hellas

sr. manager, statistics (rwe) athens

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sr. manager, statistics (rwe)

Pfizer Hellas

european safety office (eso) medical senior manager

Pfizer Hellas

associate medical director

Pfizer Hellas