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Senior Pharmacovigilance Associate

hace 1 mes

Xico, México Icon A tiempo completo

At ICON, we're driven by a shared vision to advance and improve patients' lives. Our diverse teams enable us to become a better partner to our customers, and we're committed to delivering excellence in every aspect of our work.

As a Senior Pharmacovigilance Associate, you'll play a critical role in ensuring the safety of our clients' products. Your responsibilities will include:

  • Responding to medical information inquiries from healthcare professionals, consumers, regulators, and internal colleagues
  • Triage information received based on regulatory requirements and applicable SOPs
  • Completing adverse event follow-up by phone or in writing
  • Prioritizing and completing multiple projects within established time frames
  • Managing client projects, including managing client relationships and project budgets
  • Entering information for medical information inquiries into medical information databases, tracking systems, and project-specific forms
  • Maintaining a library of responses to Frequently Asked Questions and Standard Response Letters
  • Preparing Standard Response letters, including conducting literature searches and article summaries
  • Responding to medical information inquiries within pre-determined timelines and constraints
  • Identifying individual Case Safety Reports and technical product complaints and forwarding them to relevant stakeholders within pre-determined timelines
  • Assisting with or performing reconciliation of safety databases, safety tracking systems, medical information databases, product complaint database, and clinical databases
  • Monitoring and interpreting worldwide regulations pertaining to medical information and pharmacovigilance
  • Providing regulatory expertise to colleagues and clients
  • Assisting with regulatory agency inspections, client audits, and internal audits
  • Participating as an active member of multidisciplinary teams to successfully achieve project and corporate goals

Requirements for this role include:

  • Strong written and oral communication skills in English
  • Bachelor's degree completed (Doctor or Nursing)
  • At least 1 year of experience with customer service experience similar to a call center

At ICON, we offer a competitive salary package, annual bonuses, and a range of health-related benefits to employees and their families. We're an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment.