Safety Data Management Specialist with English and Spanish or Portuguese

Job description

Safety Data Management Specialist Use Your Power for Purpose At Pfizer, our purpose is clear: breakthroughs that change patients’ lives. Within Worldwide Safety, our colleagues play a critical role in protecting patients by ensuring that safety information is collected, assessed, processed, and reported accurately and on time. The EUAfME DSU Platform is part of Pfizer’s Worldwide Safety organization and supports Drug Safety Units across Europe, Africa, and the Middle East. Our team provides high-level expertise in Individual Case Safety Report processing and assessment, as well as other pharmacovigilance activities that help ensure Pfizer products remain safe and effective for patients worldwide. What You Will Achieve As a Safety Data Management Specialist, you will join Pfizer’s safety world and contribute directly to pharmacovigilance operations that support regulatory compliance and patient safety. You will work in a structured, quality-driven environment, following established procedures while developing expertise in safety data handling, case processing, and cross-functional collaboration. In this role, you will: Review, rank, verify, process, and document case-related information, including event terms, validity, seriousness, special scenarios, timelines, accuracy, and consistency. Determine the appropriate workflow for case processing by reviewing case criteria and identifying cases requiring escalation. Prepare, complete, and verify adverse event reports to support assessment of Pfizer product safety and meet regulatory requirements. Perform follow-up activities to obtain additional information from reporters when needed. Support preliminary assessment of adverse event reports received from sources such as the European Medicines Agency and other intake channels. Contribute to E2B acceptance and case verification activities, supporting intake into Pfizer safety systems. Review processed cases for completeness, consistency, compliance with process requirements, and special scenarios. Support submission and distribution activities for processed and medically assessed reports to relevant external parties, including health authorities, ethics committees, and investigators where applicable. Participate in literature screening and translation-related activities across the EUAfME region. Liaise with Drug Safety Units and cross-functional partners such as Medical Information, Product Complaints, Regulatory, and other stakeholders to support safety data collection and reconciliation. Develop and maintain knowledge of applicable corporate policies, global and local regulations, standard operating procedures, data-entry conventions, and safety database search functions. What You Will Learn This position offers a strong foundation in pharmacovigilance and safety operations. You will gain practical knowledge of Individual Case Safety Report processing, safety data quality, regulatory timelines, follow-up management, submissions, literature-related processes, and collaboration across a regional safety platform. You will also have the opportunity to build expertise in the area that interests you most and contribute to improvements that make our processes more efficient, consistent, and patient-focused. Here Is What You Need Minimum requirements: Bachelor’s degree; a degree in life sciences, pharmacy, medicine, biotechnology, public health, or a related field is an additional asset. Fluent spoken and written English and Spanish or Portuguese (minimum B2) Strong interest in patient safety, medicines, healthcare, or pharmacovigilance. Analytical mindset with the ability to review detailed information accurately and consistently. Excellent written and verbal communication skills. Ability to work in a structured environment, follow procedures, and meet quality and compliance expectations. Collaborative, service-oriented approach and motivation to contribute to team success. Demonstrated computer literacy and willingness to learn safety databases and digital tools. Bonus Points If You Have Previous experience or education in pharmacovigilance, drug safety, clinical research, regulatory affairs, medical information, quality, or healthcare. Familiarity with medical terminology, adverse event reporting, or coding systems. Knowledge of additional foreign languages, especially languages used across the EUAfME region. Experience working with databases, structured documentation, or process-driven environments. Strong problem-solving skills and the ability to identify issues and escalate them constructively. Curiosity about automation, digital transformation, and responsible use of AI tools such as Microsoft Copilot or similar technologies to support productivity and continuous improvement. What we offer: Job contract in Pfizer Minimum annual gross base salary of 100 500 PLN Annual bonus: 10% Customized benefits package (e.g. medical care, life insurance, Multisport, Christmas gifts, educational workshops and trainings, language learning support, etc.) International and supportive culture with development opportunities. Apply Now If you are detail-oriented, curious, motivated by patient safety, and ready to grow in a global pharmacovigilance environment, we would be excited to hear from you. Join Pfizer and help us deliver breakthroughs that change patients’ lives. Work Location Assignment: Hybrid Purpose Breakthroughs that change patients' lives... At Pfizer we are a 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. Digital Transformation Strategy One 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 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. Let’s start the conversation! Equal Employment Opportunity 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! Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. 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 o