Safety Expert

hace 1 semana


Xico, México Thermo Fisher Scientific A tiempo completo
Job Description:

We are seeking a skilled Safety Expert - Pharmacovigilance Specialist to join our team at Thermo Fisher Scientific.

Overview:

As a Safety Expert, you will play a crucial role in ensuring the safety of our clients and their patients by overseeing day-to-day pharmacovigilance activities. This includes collecting, monitoring, assessing, evaluating, researching, and tracking safety information.

Responsibilities:
  • Perform day-to-day pharmacovigilance activities independently or as part of a team
  • Collaborate with project team members, client contacts, investigators, adverse event reporters, and third-party vendors to ensure seamless communication and efficient issue resolution
  • Operate in a lead capacity, providing guidance and mentorship to less experienced staff members
  • Develop and maintain procedural documents, prepare for and attend audits, and review regulatory/pharmacovigilance publications and information sources to stay updated on current regulations and practices
  • Review cases entered for quality, consistency, and accuracy, including peer reports
  • Participate in routine project implementation and coordination, including presentations at client/investigator meetings and review of metrics and budget considerations
Requirements:
  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification
  • At least 5 years of experience in pharmacovigilance or a related field, with a thorough understanding of pathophysiology and disease processes
  • Excellent critical thinking and problem-solving skills, with the ability to evaluate and escalate issues appropriately
  • Proficiency in clinical study administration, including budget activities and forecasting
  • Excellent oral and written communication skills, including paraphrasing and translation skills where required
  • Computer literacy and proficiency in Microsoft Office products, including Outlook, Word, and Excel
  • Thorough understanding of global regulatory requirements and compliance with procedural documents and regulations
  • Ability to manage and prioritize multiple tasks, meet strict deadlines, and maintain attention to detail
  • Strong attention to detail and ability to work effectively within a team
What We Offer:
  • Competitive salary: $80,000 - $110,000 per year
  • Annual incentive plan bonus
  • Comprehensive healthcare package
  • Range of employee benefits
  • Opportunities for career growth and development
  • A dynamic and innovative work environment


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