Apprentice Drug Safety

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 19 hours ago

Vacancies: 1 Vacancy

Job 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 masters 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.

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 a...