Senior Safety Data Specialist

hace 7 días


Xico, México Novasyte A tiempo completo

Job Overview


As a Senior Safety Data Specialist, you will play a key role in reviewing, assessing, and processing safety data and information across various service lines. This involves receiving data from multiple sources, analyzing it, and distributing reports to both internal and external stakeholders while adhering to applicable regulations and guidelines.


Key Responsibilities:



  • To prioritize and complete assigned trainings on time.
  • Process safety data according to relevant regulations, guidelines, standard operating procedures (SOPs), and project requirements.
  • To perform Pharmacovigilance activities as per project requirements, including but not limited to collecting and tracking incoming adverse events (AE)/endpoint information, determining initial/update status of incoming events, database entry, coding AE and products, writing narratives, literature-related activities as per internal/project timelines.
  • Ensure quality standards are met per project requirements.
  • Meet productivity and delivery standards per project requirements.
  • To ensure compliance with all project-related processes and activities.
  • Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
  • Work towards ensuring individual training plans and training transcripts are reconcilable.
  • Creating, maintaining, and tracking cases as applicable to the project plan.
  • Identify quality problems, if any, and bring them to the attention of a senior team member.

Qualifications:


We are seeking a highly organized individual with strong communication skills to fill this role. Ideal candidates will have a Bachelor's degree in life sciences or a related field and up to 3 years of relevant experience, inclusive of up to 1 year of Pharmacovigilance experience. Additionally, they should possess strong organizational skills and time management skills, be able to follow instructions/guidelines, utilize initiative, and work independently.


Benefits:


As a Senior Safety Data Specialist, you can expect a competitive salary of $65,000 - $80,000 per year, depending on location and experience. We also offer opportunities for career growth, professional development, and a collaborative work environment. If you are a motivated and detail-oriented individual looking to advance your career in the pharmaceutical industry, we encourage you to apply.



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