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Ανθρώπινο Δυναμικό / HR

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JOB SUMMARY<ul><li>A highly productive, independent statistical data sciences lead ensuring excellence in the delivery of analysis ready datasets, analysis results, and displays such as tables, listings, and figures to advance research, development, and commercialization of the Pfizer portfolio following Pfizer SOPs and processes.</li><li>Ensures adherence to high quality statistical data sciences principles, processes and techniques in the production of clinical reports.</li><li>This role is the statistical data sciences point of contact at the study level, and will support at the asset/submission level.</li></ul>JOB RESPONSIBILITIES<ul><li>Will deliver through combination of oversight of in-house statistical data scientists / vendors / offshore support as well as through hands on application of statistical data sciences techniques (e.g., use of tools such as SAS, R, and Python to process clinical trial data and big data sources such as Real World Evidence to inform decision making).</li><li>Works with department leadership and project teams to establish strategy, timelines, and resourcing of deliverables for their study(ies).</li><li>Accountable for the quality and timely delivery of datasets, analysis results and displays required for their clinical study reports as well as other asset level deliverables they may contribute to under the leadership of the asset lead.</li><li>Ensures appropriate documentation across the lifespan of the study for deliverables and verifies proper Trial Master File filings when appropriate.</li><li>Ensures planning is in place for all deliverables including consideration of special data types and downstream uses of data.</li><li>Works with statisticians, statistical data science resources and other colleagues as appropriate to ensure clear specifications for deliverables are in place.</li><li>Will be knowledgeable in core safety standards as well as Therapeutic Area standards or Industry data standards for unique data types pertinent to their project. May aid in development of standards necessary for their study or asset.</li><li>Will contribute to department level initiatives.</li><li>Proactive at communicating potential issues to upper management.</li><li>Anticipates and solves routine problems, while developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.</li><li>Supervises and supports a team, fostering collaboration and continuous improvement.</li></ul>QUALIFICATIONS / SKILLS<ul><li>Bachelor’s or Master’s (preferred) Degree in Statistics, Data Sciences, Biological Sciences, IT, or related field.</li><li>At least 5 years relevant experience in a pharmaceutical, biotech, CRO, or Regulatory Agency.</li><li>Clinical trials expertise with a thorough understanding of data operations required for the reporting of clinical trial data.</li><li>Good understanding of ICH and Regulatory Guidelines including submission requirements and data conformance (e.g., Pinnacle21).</li><li>Statistical Programming and SAS, R, or Python hands-on experience.</li><li>Familiarity with R packages, Shiny Apps, Markdown reports and other associated data science and data analytics tools and AI/ML highly desired.</li><li>Experience with Real World Evidence and other big data sources and associated standards (e.g.OMOP, JSON, ODHSI ) in support of regulatory filings desired.</li><li>Active participation in relevant industry groups (e.g., PHUSE, CDISC, IHD).</li><li>Routine problem solving skills, developing the ability to solve complex problems using skills based on experience and extrapolation to new situations.</li><li>Thorough understanding of clinical data and relevant data standards (e.g., CDISC).</li><li>Extensive knowledge of routine statistical methodology and its application to statistical data sciences.</li><li>Knowledge of vendor processes.</li><li>Demonstrated experience in developing successful partnerships within study teams.</li><li>Strong written and oral communication skills, and project management skills.</li><li>Ability to present technical information to a non-technical audience.</li><li>Proven ability to operate independently.</li><li>Some exposure working across international boundaries and cultures.</li><li>Ability to manage customer expectations.</li><li>Ability to manage work of others in a remote and/or global setting.</li></ul>

Manager, Statistical Data Sciences Lead Thessaloniki

Our HR team is&nbsp;comprised&nbsp;of dedicated, solution oriented and agile colleagues who think big, challenge the status quo to create room for meaningful work. The position is a great opportunity for a career development or a zig zag movement providing great exposure to HR processes of the EMEA region.Being part of the global Pfizer workforce provides access to HR knowledge, state-of-the-art HR systems and skills building while working in an amazing workplace. Whether you have experience in HR, in a business center or in an operations environment, your diverse perspectives and knowledge will contribute to shape our workforce and help patients across the globe. &nbsp;Join a multinational, high qualified, inclusive, and amazing team.What You Will Achieve&nbsp;You’ll&nbsp;have a key role to play in an organization that has people at its heart.As part of the EMEA Colleague Services Delivery team, you will&nbsp;be supporting HR operational tasks for the markets of responsibility.Ensure compliance, support colleague’s request via a ticketing system, manage colleague’s records and documentation, provide colleague’s information for analysis and decision-making, managing stakeholders and supporting day to day operational tasks are part of your daily activities.As an associate, your focus on the job will contribute to achieving project tasks and goals.&nbsp;How You Will Achieve It&nbsp;<ul><li>Support HR operational tasks for the markets of responsibility as part of the EMEA Colleague Services Delivery team.</li><li>Execute HR pay-impacting tasks that support the entire employee lifecycle.</li><li>Contribute to completion of projects and organize own work to meet project task deadlines.&nbsp;</li><li>Support team in overall HR operations.&nbsp;</li><li>Conduct root cause analysis to improve standardization and efficiency.</li><li>Support stakeholder Mgt in operational calls.</li><li>Administer and maintain documentation such as Standard Operating Process (SOP) or Work Instructions (WI).</li><li>Ensure timely attention to the requests and concerns of colleagues received from various means.&nbsp;</li><li>Prepare regular reports.</li><li>Create and maintain employee records.&nbsp;</li><li>Support and deliver continuous improvement initiatives.</li><li>Participate and execute audits of HR process data to ensure alignment with compliance regulations.&nbsp;</li><li>Support the implementation and maintenance of consistent process and operational efficiencies across all sites.&nbsp;</li><li>Assist&nbsp;and support team&nbsp;on research and analysis on HR related matters.</li></ul>Qualifications&nbsp;Must-Have&nbsp;<ul><li>Minimum of a bachelor's Degree</li><li>B2-C2 level in Italian language (written and verbal).</li><li>C1–C2 level in English language (written and verbal).</li><li>Proficient in MS Office.&nbsp;&nbsp;</li><li>Possesses a positive, continuous improvement mindset.&nbsp;</li><li>Demonstrated capability to work as a team member in a matrix environment.&nbsp;</li></ul>Nice-to-Have&nbsp;<ul><li>Experience of working on ERP HR module (SNOW -ticketing systems).&nbsp;</li><li>Experience of working in a Service Center.</li><li>Experience in operations.</li><li>Positive, self-motivated with strong sense of responsibility.&nbsp;</li><li>Knowledge of various analytical tools.&nbsp;</li></ul>&nbsp;&nbsp;Please apply by sending your CV and a motivational letter in English

Service Delivery Associate, GBS CS, Core HR Services, Italian Speaker (6 months fixed term)

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 - Page 2

manager, statistical data sciences lead thessaloniki

Pfizer Hellas

service delivery associate, gbs cs, core hr services, italian speaker (6 months fixed term)

Pfizer Hellas

european safety office (eso) medical senior manager

Pfizer Hellas

associate medical director

Pfizer Hellas