Fortrea Hiring Safety Writer (Aggregate Reports & QMS)
Are you seeking Fortrea Careers Mumbai or a Pharmacovigilance Medical Writing Job in Pune? Global Contract Research Organization (CRO) leader Fortrea is recruiting experienced medical writers for the position of Safety Writer (Job ID: 2637).
This aggregate safety report writing vacancy is ideal for life sciences, nursing, or pharmacy graduates with a minimum of 3 years of pharmaceutical experience, including at least 2 years focused on regulatory safety writing. Selected candidates will draft PSURs, DSURs, PADERs, Risk Management Plans (RMPs), and prepare patient adverse event narratives. To write a resume detailing your aggregate review drafts, safety database access, or literature search milestones, read our guidelines on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particular | Details |
|---|---|
| Company | Fortrea (Fortrea Scientific Private Limited) |
| Position | Safety Writer |
| Job ID | 2637 |
| Job Location | Mumbai / Pune, India (Office-Based) |
| Employment Type | Full-Time |
| Experience Required | 3+ Years in Pharma (with 2+ years core Medical Writing experience) |
| Qualifications | First Degree in Life Sciences / Pharmacy (B.Pharm, M.Pharm, Pharm.D, B.Sc, M.Sc, Ph.D) |
| Travel Requirement | Minimal (Up to 5%) |
💼 Key Responsibilities
- Aggregate Reports: Write, compile, and format Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and PADERs.
- Risk Management: Author Risk Management Plans (RMPs) and compile clinical Common Technical Document (CTD) summaries.
- Quality Audits: Perform detailed quality reviews on reports prepared by associate and junior medical writers.
- Literature Searches: Conduct systematic scientific literature database searches and draft summaries for routine surveillance dossiers.
- Safety Narratives: Draft clinical adverse event case narratives and compile medical responses for healthcare professionals (HCPs).
- Labeling Reviews: Help draft and update product label content including Core Data Sheets and Patient Medication Guides.
To learn how medical writing and safety reporting salaries compare to conventional pharmacovigilance drug safety associate and clinical data programming roles, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Skills
- Education: Bachelor's or Master’s degree in Life Sciences, Pharmacy, or equivalent advanced scientific qualifications (M.Pharm, PhD).
- Writing Experience: Minimum 2 years of core medical writing experience in compiling clinical or safety regulatory reports.
- Guidelines Awareness: In-depth understanding of ICH-GCP guidelines, safety regulations, and pharmacovigilance practices.
- Communication: Outstanding command of written and spoken English, detailing complex clinical datasets.
- Software Skills: Proficient in using MS Office suite (Word and Excel templates) and safety information databases.
For science graduates evaluating safety medical writing pathways compared to conventional laboratory quality control or direct formulation chemist roles, read our analysis on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join Fortrea?
- Work inside a leading global CRO supporting multinational biopharmaceutical sponsors.
- Advance your technical expertise by authoring complex, high-impact clinical overviews and signal safety reports.
- Collaborative global project environment with direct sponsor contact.
- Competitive corporate salary package and career progression training.
To review your basic knowledge of clinical databases, safety protocols, and GCP guidelines before your screening assessments, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 Safety Writer vs Healthcare IT
Safety Writers draft aggregate safety profiles, review literature abstracts, and audit labeling updates, whereas Healthcare IT professionals support software deployments. To explore these differences, read our comparison on Healthcare IT vs Clinical Healthcare.
📝 Resume Tips for Fortrea Writing Candidates
- Specify Report Types: Explicitly mention aggregate reports you have authored (e.g. "Drafted 10+ PSURs and 5+ DSURs").
- Highlight Literature Databases: List specific indexing platforms you have searched (such as PubMed, Embase, or Cochrane Library).
- Emphasize Quality Review: If you have mentored junior writers or conducted QC on peer documents, detail it.
💬 Fortrea Safety Writer Interview Questions
- Q1. What is the primary purpose of a Development Safety Update Report (DSUR)?
Answer Guidance: A DSUR is a periodic safety report compiled during the clinical development phase of an investigational drug. Its main purpose is to present a comprehensive, annual safety review of the drug, ensuring that sponsors and regulatory authorities monitor clinical trial subject safety. - Q2. How do you approach writing an adverse event narrative for a clinical study?
Answer Guidance: I compile the patient demographics, medical history, details of drug administration, description of the adverse event, lab findings, treatments provided, investigator causality assessment, and the final clinical outcome. - Q3. Explain the difference between a PSUR and an RMP.
Answer Guidance: A PSUR (Periodic Safety Update Report) is a retrospective safety review of a marketed drug over a specific time. An RMP (Risk Management Plan) is a forward-looking document that outlines known safety risks, lists missing information, and details plans to monitor and minimize those risks post-approval.
🚀 How to Apply?
Interested and eligible candidates can submit their applications directly via Fortrea's official Workday careers board. Click the button below to apply:
Apply Online – Fortrea Workday Career Board❓ Frequently Asked Questions
Q. Do I need experience drafting aggregate safety reports to apply?
Yes, Fortrea requires candidates to have a minimum of 2 years of core medical writing experience, preferably drafting aggregate safety and risk management dossiers.
Q. Are Ph.D. or Master's graduates preferred for this role?
Yes, advanced degrees (M.Sc., M.Pharm, or Ph.D.) are highly preferred by the hiring managers.
Q. What is the location and work arrangement for the Safety Writer position?
This is a full-time, office-based position located at Fortrea's offices in Mumbai and Pune, India.
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