Safety Surveillance Associate

hace 4 días


San José, San José, Costa Rica Pfizer A tiempo completo
About the Role

We are seeking a highly skilled Safety Surveillance Associate to join our team at Pfizer. This role will involve reviewing and preparing reports of adverse drug experiences, determining the safety profile of Pfizer's products, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Identify routine cases for processing, prioritizing them based on complexity and urgency.
  • Assess cases to distinguish those with particular complexities and/or specific issues, escalating them as needed.
  • Review, rank, verify, process, and document event terms, case classifications, special scenarios, product complaint information, reportability, accuracy, and consistency.
  • Determine the appropriate workflow for case processing based on assessment.
  • Write and edit case narratives.
  • Generate reports, adhering to regulatory compliance timelines.
  • Determine appropriate case follow-up, requesting follow-up letters when necessary.
  • Liaise with key partners regarding safety data collection and data reconciliation.
  • Develop and maintain expertise in all products within the Pfizer portfolio, applicable regulations, guidelines, Standard Operating Procedures, writing practices, data entry conventions, and search functions in the safety database.
Requirements
  • Bachelor's degree in a science-related field, pharmacy, nursing, or equivalent; healthcare professional qualification preferred.
  • Health Care Professional (HCP) qualification an advantage.
  • Able to solve routine problems, surface issues constructively, make basic decisions, and understand consequences.
  • Familiarity with ARGUS safety database.
Desirable Qualifications
  • Experience in pharmacovigilance, clinical care, or clinical/scientific research.
  • Knowledge of additional languages an advantage.
  • Experience and skill with medical writing an advantage.
Work Arrangement

This is an on-premise role, requiring regular presence at a Pfizer site. Some flexibility to work remotely may be available.

Equal Opportunities Employer

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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.

Salary Range: $80,000 - $110,000 per annum, depending on experience.



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