Apprentice - Drug Safety
2 days ago
- 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
- 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.
- 0 to 6 months of experience in Pharmacovigilance.
- Bangalore (Office Based)
Learn more about our EEO & Accommodations request here.
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