Escazu, Costa Rica
15 hours ago
Safety Data Management Specialist (Temporal 12 Meses)

Use Your Power for Purpose

Our mission is straightforward: empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.

What You Will Achieve

In this role, you will:

Monitor and manage the company's drug, biologics, and medical devices surveillance program, ensuring comprehensive oversight.Intake, evaluate, and process adverse reports for both clinical trials and post-marketing activities, ensuring accurate and timely handling.Act as a subject matter expert, liaising with key partners regarding safety data collection, reconciliation, and ensuring regulatory compliance.Review, analyze, prepare, and complete safety-related reports to determine the safety profile of products and meet regulatory requirements.Verify the accuracy, consistency, and compliance of processed cases, and review case data for special scenarios, ensuring high standards are maintained.Manage safety resources within the local team, provide specific pharmacovigilance or product knowledge, mentor colleagues, and maintain advanced knowledge of Pfizer's product portfolio and corporate policies.

QualificationsMust-HaveBachelor's Degree in Health Science1+ years' experienceDemonstrated organizational/project management skillsSolid knowledge of global regulations and guidelines for drug developmentDemonstrated analytical and statistical skill.Ability to make decisions independently and resolve issues appropriatelyStrong skills in productivity, organizational and time management in order to meet strict regulatory compliance goalsFluent in spoken and written English

 

Nice-to-HaveMaster's degreeRelevant pharmaceutical industry experienceFamiliarity with management of performance metricsAbility to make decisions independently in both routine case processing and unique and/or complex situations, and to resolve issues appropriately to achieve a desired result or impactProfessional proficiency in Portuguese and/or French  
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.

Medical

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