Safety Specialist

2 semanas atrás


São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

**Job Summary**

Thermo Fisher Scientific is seeking a highly skilled Pharmacovigilance Specialist to join our team. As a key member of our Pharmacovigilance team, you will be responsible for performing day-to-day Pharmacovigilance activities within a highly regulated environment.

**Key Responsibilities**

  • Collection, monitoring, assessment, evaluation, research, and tracking of safety information
  • Coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities
  • Collaboration with project team members, client contacts, investigators, and adverse event/reporters, and third-party vendors
  • Preparation of departmental and project-specific procedures and processes, preparation for and attendance at audits, kick-off, and investigator meetings

**Requirements**

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years)
  • General understanding of pathophysiology and the disease process
  • Detailed knowledge of relevant therapeutic areas as required for processing AEs
  • Strong critical thinking and problem-solving skills
  • Good oral and written communication skills, including paraphrasing skills
  • Computer literate with the ability to work within multiple databases
  • Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
  • Understanding the importance of and compliance with procedural documents and regulations
  • Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
  • Strong attention to detail
  • Ability to maintain a positive and professional demeanor in challenging circumstances
  • Ability to work effectively within a team to attain a shared goal

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