job title: drug safety - apprentice(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.

Location : Bangalore

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 (Minimum Required): • Attention to detail. • Team player. • Solid written and verbal communication skills. • Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data. • Knowledge of MS office Windows applications beneficial. • Ability to operate standard office equipment.