Apprentice - Drug Safety

3 weeks ago


Bengaluru, Karnataka, India Lifelancer Full time

Job Title: Apprentice - Drug Safety

Job Location: Bengaluru, Karnataka, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Internship

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.

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.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

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.

For more information about how we collect and store your personal data, please see our Privacy Statement.

If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: . Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

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