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Regulatory Specialist

hace 1 mes


Ciudad de México, Ciudad de México Teva Pharmaceuticals A tiempo completo

Job Title: Regulatory Specialist

Salary: $60,000 - $80,000 per year

About the Role:

We are seeking a highly skilled Regulatory Specialist to join our Pharmacovigilance team at Teva Pharmaceuticals. In this role, you will be responsible for performing pharmacovigilance activities within the North America PV unit, in partnership with the Drug Safety Specialists/Pharmacovigilance Safety Specialists and Pharmacovigilance Managers/Director.

Key Responsibilities:

  • Intake of adverse event information, including extraction, upload, and intake of XMLs
  • Performs case registration of adverse event reports by entering searchable information
  • Sending adverse event information to license partners within the required timeline as per pharmacovigilance agreement
  • Collecting additional information from reporters and performing follow-up with healthcare professionals and consumers
  • Review and assessment of reportability of the adverse event to FDA/Health Canada as applicable
  • Receiving, reviewing, and performing all necessary actions pertaining to negative acknowledgements for FDA and Health Canada as applicable
  • Participate in Pharmacovigilance audits and inspections as needed
  • Drafting and finalizing CAPAs as needed for late submissions and non-compliance with internal processes
  • Complete all training and SOP/WI reviews in a timely manner
  • Assist in updating and revising SOPs/WIs whenever processes and procedures are changed to comply with new regulations or to improve procedures or make them more efficient
  • Train all new hires in PhV on systems and processes relating to pharmacovigilance activities and present information/training in Face-to-Face settings
  • Perform daily, weekly, and/or monthly reconciliations of adverse event reports with identified partners and programs as required by Pharmacovigilance Agreements, as well as source documents received from other internal departments where required

Requirements:

  • Bachelor of Science (Physics, Chemistry, Biology, Biochemistry, Microbiology, Physiology, Anatomy, Pharmacology)
  • 1-3 years Global experience of pharmaceutical industry or CRO experience and at least 1 year of Pharmacovigilance experience
  • Demonstrates proficiency with Microsoft Office Word, Excel, PowerPoint, and Adobe Acrobat
  • Knowledge of PhV IT systems such as Arisg, Argus, Cognos is an added advantage
  • Demonstrates teamwork, critical thinking, and good communication skills

What We Offer:

  • A competitive salary range of $60,000 - $80,000 per year
  • A comprehensive benefits package
  • Ongoing training and development opportunities
  • A dynamic and supportive work environment

If you are a motivated and detail-oriented individual with a passion for pharmacovigilance, we encourage you to apply for this exciting opportunity.