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Safety Science Coordinator - I

1-2 years
Not Disclosed
10 Aug. 23, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Fortrea is a leading global Contract Research Organization (CRO) with a strong commitment to scientific excellence and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device clients with comprehensive solutions in clinical development, patient access, and technology across over 20 therapeutic areas. With a dedicated team of more than 19,000 professionals across 90 countries, Fortrea is at the forefront of transforming drug and device development for partners and patients worldwide.

Job Description:

In this role, you will:

  • Safety Report Processing: Assist with the processing and submission of Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs). Maintain adverse event tracking systems and project files, ensuring timely reporting to clients, Regulatory Authorities, Ethics Committees, investigators, and Fortrea project personnel.
  • Adverse Event Management: Log all incoming Adverse Event (AE) and Serious Adverse Event (SAE) reports into departmental tracking systems and forward to the centralized mailbox. Perform data entry, write patient narratives, and code adverse events accurately using MedDRA.
  • Compliance and Quality: Ensure adherence to governing regulatory requirements and internal SOPs. Assist with the peer/quality review of processed reports, support trend analysis, and manage reconciliation of databases. Maintain files on adverse event reporting requirements and support safety study file archiving.
  • Administrative Support: Schedule and coordinate internal and external meetings and teleconferences. Train and mentor PSS Assistants and peers, build strong relationships across functional units, and provide administrative support to PSS personnel.
  • Process Improvement: Proactively identify opportunities for process enhancements and support implementation. Ensure the quality and accuracy of data processed and maintain compliance with project-specific plans.

Experience and Qualifications:

  • Minimum Required:
    • Strong team player with the ability to set priorities and handle multiple tasks.
    • Excellent written and verbal communication skills.
    • Attention to detail with proficiency in handling and proof-reading numerical data.
    • Basic knowledge of MS Office and standard office equipment.
  • Preferred:
    • 1-2 years of experience in Drug Safety.

Location: Bangalore

Why Join Fortrea?

Fortrea is seeking innovative problem-solvers who share our dedication to overcoming challenges in clinical trials. Our goal is to revolutionize the development process, ensuring rapid delivery of life-changing therapies to patients. Join our collaborative team to experience personal growth and make a global impact.

Equal Opportunity Employer:

Fortrea is proud to be an Equal Opportunity Employer. We are committed to fostering a diverse and inclusive workforce and do not tolerate discrimination or harassment of any kind. Employment decisions are based on business needs and individual qualifications, regardless of race, religion, color, national origin, gender, family status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic. We encourage all qualified individuals to apply.

For details on how we handle your personal data, please refer to our Privacy Statement. Learn more about us at www.fortrea.com.