Regulatory Compliance Specialist

hace 1 semana


San José, San José, Costa Rica Pfizer A tiempo completo
**About Us**

Pfizer is a mission-driven company that empowers healthcare decisions regarding the safe and appropriate use of medicines for patients. Our team strives to improve patient care and treatment efficacy by ensuring our evidence is sound and offering necessary medical insights.

**Job Description**

In this role, you will be responsible for reviewing, preparing, and completing reports of adverse drug experiences to determine the safety profile of Pfizer's products and meet regulatory requirements.

  • Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
  • Assess cases to distinguish those with particular complexities and/or specific issues and escalate appropriately.
  • Review, rank, verify, process, and document event terms; case classifications; special scenarios; product complaint information; reportability; and accuracy and consistency.

You will also generate reports, ensuring adherence to regulatory compliance timelines, and liaise with key partners regarding safety data collection and data reconciliation.

**Required Skills and Qualifications**
  • Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent.
  • Healthcare professional qualification preferred.
  • Demonstrated computer literacy, particularly in the use and management of relational databases.
  • Excellent oral and written communication skills.
  • Fluency in spoken and written English; knowledge of additional language(s) an advantage.
**Benefits**

Pfizer offers a dynamic work environment, opportunities for growth and development, and a competitive compensation package.



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