Safety Data Management Specialist with English and Spanish or Portuguese

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 Pfizers 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 Pfizers 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:

• Bachelors 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

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

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