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Safety Writing Assistant Ii

0-2 years
Not Disclosed
10 Feb. 13, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Safety Writing Assistant II

Location: Mumbai

Category: Clinical

Job ID: 2443859

Description:

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 approximately 100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Key Responsibilities:

  • Perform allied activities such as generating outputs/reports from databases or safety systems, distributing data requests, calculating sales data, conducting regulatory website searches, and collating report planning materials.
  • Author parts of various safety reports for global regulatory submissions, including but not limited to:
    • Annual Reports (IND and others)
    • Periodic Safety Update Reports
    • Periodic Adverse Drug Experience Reports
    • Periodic Benefit-Risk Evaluation Reports
    • Development Safety Update Reports
    • Risk Management Plans
    • Other assigned documents
  • Develop assigned report sections, which may include:
    • Using pre-populated template text
    • Reusing content from other documents
    • Conducting low to medium complexity safety analyses
  • Review and annotate line listings, prepare case narratives or data summaries, and present data per the approved strategy.
  • Participate in comment resolution discussions for assigned sections.
  • Support medical writers in signal detection activities, including:
    • Data cleaning
    • Reviewing and annotating line listings
    • Creating supporting materials for signal review meetings
    • Preparing parts of signal reports

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.

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. Employment decisions are based on business needs and individual qualifications, without discrimination based on 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.

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

Accommodation Requests:
If 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:
taaccommodationsrequest@fortrea.com. This email is only for job seekers requesting accommodation and should not be used to check the status of an application.