Safety Specialist

hace 4 semanas


Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As a key member of our team, you'll play a vital role in bringing our mission to life by delivering high-quality Pharmacovigilance (PV) services.

Key Responsibilities:

  • Perform day-to-day PV activities, including collection, monitoring, assessment, evaluation, research, and tracking of safety information.
  • Collaborate with project team members, client contacts, investigators, and adverse event reporters to ensure seamless communication and timely resolution of issues.
  • Develop and maintain procedural documents, prepare for and attend audits, and mentor less-experienced staff to ensure compliance with regulatory requirements.
  • Stay up-to-date on current regulations, practices, and proposals by reviewing regulatory/pharmacovigilance publications and information sources.
  • Review cases entered for quality, consistency, and accuracy, including review of peer reports.

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 5+ years).
  • Thorough understanding of pathophysiology and the disease process.
  • Solid understanding of relevant therapeutic areas as needed for processing adverse events.
  • Excellent critical thinking and problem-solving skills with the ability to evaluate and escalate appropriately.
  • Proficient in sophisticated clinical study administration, including budget activities and forecasting.
  • Excellent oral and written communication skills, including paraphrasing skills.
  • Good command of English and ability to translate information into local language where required.
  • Computer literate with the ability to work within multiple databases.
  • Proficient in Microsoft Office products (including Outlook, Word, and Excel).
  • Thorough understanding of the global regulatory requirements and the importance of 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 exciting circumstances.
  • Ability to work effectively within a team to attain a shared goal.

What We Offer:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.


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