Apprentice - Drug Safety
7 hours ago
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
**Apprenticeship Program: Job Description**:
**Apprentice**:Apprentice Drug Safety**:
**Company Overview**:
**As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.**:
**India Apprentice Program**:
**Exciting opportunity to be part of the Fortrea India Apprentice Program**:
**_ As a Fortrea Apprentice, you will have the opportunity to support meaningful_**_ assignments that compliment an education in STEM+ Business and Healthcare disciplines and are inspiring and valuable in our mission to improve health and improve lives across the globe._**:
**_ Capitalize on a dedicated training and development program that will support your scientific and professional career aspirations and take pride in delivering work that helps save the lives of millions of people around the world._**:
**About Team**:
- **_ The Patient safety solutions (PSS) department provides a range of services for clients including the collection, assessment, and distribution of individual case safety reports and aggregate safety reports._**:
**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._**:
**Fortrea is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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