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Safety Writer Job at Fortrea Medical Writing Role

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Apply for Safety Writer at Fortrea Mumbai. Check eligibility, pharmacovigilance role details, salary, experience required, and apply online today now.

Introduction

The Safety Writer at Fortrea 2026 is a promising opportunity for professionals with experience in pharmacovigilance and medical writing. This role focuses on preparing high-quality safety documents, managing regulatory reports, and collaborating with global teams. If you have a background in life sciences and strong writing skills, this position can help you advance your career in drug safety and regulatory writing.


Job Overview

Job TitleSafety Writer
Company NameFortrea
LocationMumbai, India
Employment TypeFull-Time
DepartmentPharmacovigilance / Medical Writing
Experience RequiredMinimum 2–3 Years
EducationLife Sciences Degree (B.Pharm / M.Pharm / MSc / PhD)
SalaryAs per company standards

Company Overview

Fortrea is a globally recognized contract research organization specializing in clinical development, regulatory services, and pharmacovigilance. The company collaborates with pharmaceutical and biotechnology firms to ensure safe and effective drug development. With a strong emphasis on compliance and scientific integrity, Fortrea provides professionals with opportunities to work on global regulatory projects and enhance their expertise.


Job Location & Employment Type

  • Location: Mumbai, Maharashtra
  • Employment Type: Full-Time

Open Positions / Department Details

This role is part of the Pharmacovigilance and Medical Writing team, responsible for preparing safety reports, regulatory documents, and benefit-risk assessments for global submissions.


Key Roles & Responsibilities

  • Prepare and review aggregate safety reports for global regulatory submissions
  • Write documents such as:
    • Periodic Safety Update Reports (PSUR)
    • Development Safety Update Reports (DSUR)
    • Risk Management Plans (RMP)
    • Annual safety reports and adverse event summaries
  • Conduct scientific literature searches and summarize findings for safety evaluation
  • Perform quality review of reports prepared by junior medical writers
  • Contribute to benefit-risk assessment reports and signal detection analysis
  • Write clinical and non-clinical summaries as part of Common Technical Documents (CTD)
  • Prepare medical information responses for healthcare professionals
  • Draft narratives for adverse drug reactions and serious adverse events
  • Support label updates including Core Data Sheets and prescribing information
  • Collaborate with internal teams and clients for data collection and report preparation
  • Ensure compliance with regulatory guidelines and company SOPs
  • Participate in meetings, discussions, and strategy planning for report development
  • Maintain timelines and ensure high-quality deliverables
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Eligibility Criteria

Education

  • Bachelor’s degree in Life Sciences (B.Pharm, M.Pharm, MSc, or equivalent)
  • Advanced degree such as M.Pharm or PhD preferred

Experience

  • Minimum 3 years of experience in the pharmaceutical industry
  • OR at least 2 years of experience specifically in medical writing

Skills Required

  • Strong command of written and spoken English
  • Excellent scientific and medical writing skills
  • Knowledge of pharmacovigilance practices and safety reporting
  • Understanding of regulatory guidelines (ICH-GCP, global PV regulations)
  • Proficiency in Microsoft Office tools
  • Strong analytical and research skills
  • Good organizational and time management abilities
  • Effective communication and interpersonal skills
  • Ability to work collaboratively in a team environment

Salary & Benefits

  • Salary: As per company standards
  • Additional benefits may include:
    • Health insurance
    • Professional development programs
    • Exposure to global pharmacovigilance projects
    • Work-life balance initiatives
    • Training and certification opportunities

Selection Process

  • Application screening
  • HR interview
  • Technical/medical writing assessment
  • Final interview

How to Apply

Candidates can apply through the official Fortrea careers portal. Ensure your resume highlights relevant medical writing and pharmacovigilance experience.


Important Dates

  • Apply as soon as possible (no specific deadline mentioned)

Why Apply for This Job?

  • Opportunity to work in a global pharmacovigilance and medical writing environment
  • Exposure to international safety reporting standards
  • Career growth in drug safety and regulatory writing
  • Work on complex safety documents and benefit-risk evaluations
  • Enhance expertise in clinical and regulatory documentation
  • Collaborate with global clients and cross-functional teams

This role is ideal for professionals aiming to specialize in medical writing and pharmacovigilance within the pharmaceutical industry.


FAQs

Who can apply for this job?

Candidates with a life sciences degree and relevant experience in medical writing or pharmacovigilance can apply.

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What is the salary range?

The salary is offered as per company standards and depends on experience.

Is experience required?

Yes, a minimum of 2–3 years of relevant experience is required.

How can I apply?

You can apply through the official Fortrea careers website.

What skills are important for this role?

Strong writing skills, knowledge of pharmacovigilance, regulatory understanding, and attention to detail are essential.


Conclusion

The Safety Writer at Fortrea 2026 is an excellent opportunity for professionals looking to grow in medical writing and pharmacovigilance. With responsibilities involving global safety reports, regulatory submissions, and scientific documentation, this role offers strong career advancement and industry exposure. Interested candidates should apply at the earliest.


Disclaimer

PharmaJobHub.in is an independent job information platform. We do not provide jobs or recruitment and are not affiliated with any company.


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