Safety Writing Assistant Ii

2+ years

Not Disclosed

Mumbai

10 March 19, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Safety Report Writer

Company: Fortrea, a Global Contract Research Organization (CRO)

Location: [Insert Location]

Job Overview:

Fortrea, a leading global contract research organization (CRO), is seeking a Safety Report Writer to assist with generating outputs and reports from safety databases, as well as supporting global regulatory submissions. The ideal candidate will have a strong passion for scientific rigor and a dedication to delivering high-quality reports and safety data. This role offers the opportunity to contribute to a wide range of activities, from safety analyses to report writing for regulatory submissions in the clinical development field.

Fortrea is transforming drug and device development, offering innovative solutions to pharmaceutical, biotechnology, and medical device companies across more than 20 therapeutic areas globally.

Summary of Responsibilities:

Perform allied activities, including generating outputs/reports from safety databases or systems, distributing data requests, performing sales data calculations, conducting regulatory website searches, and collating report planning materials.
Author parts of safety reports for global regulatory submissions, such as:
- Annual Reports (IND and other)
- Periodic Safety Update Reports
- Periodic Adverse Drug Experience Reports
- Periodic Benefit-Risk Evaluation Reports
- Development Safety Update Reports
- Risk Management Plans
- And other documents as assigned.
Develop assigned report sections, which may include pre-populated template text, re-use of content from other documents, or safety analyses of low to medium complexity.
Review and annotate line listings, prepare case narratives or data summaries, and present data per the approved strategy.
Participate in comment resolution discussions for the assigned sections.
Support medical writers in signal detection activities, such as:
- Data cleaning and review
- Annotating line listings
- Creating supporting materials for signal review meetings
- Preparing parts of signal reports

Qualifications (Minimum Required):

Experience in safety reporting or related activities within a clinical development or regulatory environment.
Strong attention to detail and analytical thinking skills.
Familiarity with safety systems and databases.
Ability to work independently and collaboratively in a team environment.
Good written and verbal communication skills.
Knowledge of regulatory requirements for clinical trials and safety data.

Physical Demands/Work Environment:

Office environment or remote, depending on the location and specific role needs.

Fortrea is an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea promotes diversity and inclusion in the workforce and does not tolerate harassment or discrimination. We make employment decisions based on business needs and individual qualifications without regard to 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 information about how we collect and store your personal data, please see our Privacy Statement.

If you require a reasonable accommodation to complete your job application, pre-employment testing, or to participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is for job seekers requesting accommodations only.

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Safety Writing Assistant Ii

Job Description

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