Apprentice - Drug Safety

3 days ago

Bengaluru, Karnataka, India Fortrea Full time ₹ 3,00,000 - ₹ 4,50,000 per year
Apprenticeship Summary: The Apprentice participates in and executes the entry level department functions (Designation of Apprentice) in accordance with Fortrea and/or sponsor Standard Operating Procedures (SOPs).
  • Data entry of safety data onto adverse event tracking systems.  
  • Write patient narratives & code adverse events accurately using MedDRA; WHODD (for Marketed products, if applicable).  
  • Assist in the listedness assessment against appropriate label (for Marketed products, if applicable).
  • Assist in determining causality assessment.
  • Assist in generation of queries and collection of missing or discrepant information in consultation with medical staff, if needed.
  • Submission of expedited SAE/SUSARs reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners and Fortrea project personnel, as required within the agreed timelines.
  • Assist in preparation, review, and approval of Periodic Safety Reports (PSRs) for investigational products/devices in accordance with the applicable regulations and guidelines
Education/Qualifications/Skills:
  • Educated to at least GCSE level or equivalent.
  • Has completed master's degree in Life Science.
  • Has experience delivering multiple projects in an academic or professional setting.  
  • Ability to collaborate with various stakeholders and internal/external colleagues.
  • Embraces diverse ways of thinking through various forms of collaboration and partnership.
Experience:
  • 0 to 6 months of experience in Pharmacovigilance.
Job Location:
  • Bangalore (Office Based)

Learn more about our EEO & Accommodations request here.

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