Clinical Trial Safety Associate

hace 2 semanas


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

About Our Mission
Pfizer empowers healthcare decisions regarding the safe and appropriate use of medicines for patients. Our evidence is scientifically robust, unbiased, and medically essential. We bridge data gaps to improve patient care and treatment efficacy.

What You Will Achieve in this Role
You will monitor and manage Pfizer's comprehensive surveillance program, ensuring oversight of drug, biologics, and medical devices. This includes intake, evaluation, and processing of adverse reports for clinical trials and post-marketing activities.

Your Expertise
You will act as a subject matter expert, liaising with partners on safety data collection, reconciliation, and regulatory compliance. You will review, analyze, prepare, and complete safety-related reports to determine product safety profiles and meet regulatory requirements.

Your Responsibilities
You will verify accuracy, consistency, and compliance of processed cases, reviewing case data for special scenarios. You will also manage safety resources within your local team, providing pharmacovigilance or product knowledge, mentoring colleagues, and maintaining advanced knowledge of Pfizer's product portfolio and corporate policies.

Requirements
A BA/BS with at least 2 years of experience or an MBA/MS with any years of experience is required. Strong organizational and project management skills are essential, along with solid knowledge of global regulations and guidelines for drug development. Demonstrated analytical and statistical skills are necessary, as well as fluency in spoken and written English.

Preferred Qualifications
A Master's degree and relevant pharmaceutical industry experience are preferred. Familiarity with performance metrics and strong problem-solving skills are also beneficial. Proficiency in safety database and data mart search functions is desirable.



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