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Engaged Employer

Fortrea Development India Private Limited

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3.9

based on 723 Reviews

Video summary

41 Fortrea Development India Private Limited Jobs

Apprentice - Drug Safety

Fortrea

3.9

based on 723 Reviews

0-2 years

Bangalore / Bengaluru

1 vacancy

Apprentice - Drug Safety

Fortrea Development India Private Limited

posted 3d ago

Job Role Insights

Flexible timing

Key skills for the job

Data Entry Cron Pharmacy Proof Reading Healthcare MS Office

+ 3 more

Job Description

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 (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.

Employment Type: Full Time, Permanent

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