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Safety Data Management Specialist

hace 2 semanas

San José, San José, Costa Rica Pfizer A tiempo completo

Use Your Power for Purpose
At Pfizer, our Worldwide Medical and Safety colleagues are pivotal in bridging evidence-based medical decision support with stakeholders to enhance health and treatment outcomes. Whether you are developing frameworks to ensure our evidence is scientifically robust, offering unbiased and medically essential expertise, or exploring ways to address data gaps, our mission remains clear: to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve
In this role, you will:

  • Monitor the company's drug, biologics, and medical devices surveillance program.
  • Intake, evaluate, and process adverse reports for both clinical trials and post-marketing activities.
  • Make decisions within limited options to resolve problems, under the supervisor's direction.
  • Work in a structured environment, following established procedures.
  • Ensure work is regularly reviewed for technical judgment, completeness, and accuracy.
  • Provide expertise on regulatory requirements and corporate policies for regulatory submissions to project teams.
  • Support Worldwide Strategy and Regulatory teams by analyzing post-marketing safety data, reviewing medical literature, and related activities.
  • Determine the appropriate workflow for case processing by reviewing case criteria.

Here Is What You Need
(Minimum Requirements):

  • BA/BS with any years of experience
  • Strong analytical skills with the ability to interpret complex data
  • Proficiency in using safety databases and software
  • Excellent written and verbal communication skills
  • Ability to work collaboratively in a team environment
  • Basic understanding of regulatory requirements and corporate policies

Bonus Points If You Have
(Preferred Requirements):

  • Experience in pharmacovigilance or drug safety
  • Familiarity with medical terminology and coding systems
  • Knowledge of global regulatory requirements for drug safety
  • Strong problem-solving skills and the ability to make decisions with limited information
  • Proficiency in multiple programming languages and frameworks
  • Experience with cloud platforms and services
  • Familiarity with agile methodologies and project management tools
  • Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

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