Apprentice - Drug Safety en Fortrea

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)

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