Apprentice Drug Safety

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 1 Year of Experience in Drug Safety. (Strong Experience in Clinical Trails)

Location:

 Bangalore (Office Based)

Learn more about our EEO & Accommodations request here.