Pharmacovigilance Medical Writing Vacancies at Fortrea

Safety Writer vacancies at Fortrea in Mumbai. Full-time pharmacovigilance role.

Pharmacovigilance and medical writing roles have become critical pillars of global drug safety and regulatory compliance. Fortrea is currently hiring a Safety Writer for its Mumbai operations. This role is suited for experienced life sciences professionals who want to work at the intersection of clinical research, regulatory writing, and global drug safety while supporting submissions to international health authorities.

Company Overview

Fortrea is a leading global contract research organization specializing in clinical development, pharmacovigilance, and regulatory services. Built on decades of clinical research expertise, Fortrea partners with pharmaceutical, biotechnology, and medical device companies to support the safe and compliant development of new therapies.

The organization operates across multiple regions and supports global regulatory submissions in highly regulated markets including the United States, Europe, and other international territories. Fortrea is known for its scientific rigor, operational excellence, and strong focus on patient safety and regulatory compliance.

Working at Fortrea provides professionals exposure to global safety reporting standards, complex regulatory documentation, and collaborative project teams across therapeutic areas.

Job Role & Responsibilities

The Safety Writer role is a full-time position responsible for authoring, reviewing, and managing a wide range of pharmacovigilance and regulatory safety documents.

Core Safety Writing Responsibilities

• Preparation and review of aggregate safety reports, risk management documents, and signal detection reports • Authoring global regulatory safety submissions including PSURs, PADERs, DSURs, RMPs, and annual safety reports • Acting as co-author for complex or large safety reports and supporting junior medical writers • Performing quality review of safety documents prepared by associate or junior writers • Writing benefit-risk evaluation reports and supporting documents for labeling updates • Authoring subject narratives for adverse drug reactions and serious adverse events

Regulatory & Medical Writing Activities

• Writing Common Technical Document summaries including clinical overviews, non-clinical overviews, and clinical summaries • Supporting label development and updates such as Core Data Sheets, USPI, SPCs, and Medication Guides • Authoring signal management reports and safety issue analyses • Preparing medical information responses for healthcare professionals • Conducting scientific literature searches and authoring literature summaries and abstracts • Reviewing literature search strategies and articles selected by junior team members

Project Management & Communication

• Leading kickoff meetings and round-table discussions for report planning and comment resolution • Coordinating with internal stakeholders and external clients to obtain inputs for deliverables • Managing report timelines and ensuring on-time delivery to sponsors and internal teams • Maintaining high standards of client communication and customer service

Quality & Compliance Responsibilities

• Ensuring compliance with global regulatory requirements and pharmacovigilance guidelines • Applying ICH-GCP and Good Pharmacovigilance Practices in all deliverables • Implementing standardized processes to improve quality, efficiency, and consistency • Maintaining accountability for assigned safety deliverables

Eligibility / Qualifications

This role is suitable for experienced medical writers and pharmacovigilance professionals with strong regulatory knowledge.

Minimum qualifications:

• Bachelor’s degree in Life Sciences or equivalent discipline • At least 3 years of experience in the pharmaceutical industry or minimum 2 years in medical writing • Strong understanding of pharmacovigilance regulations and safety reporting requirements • Excellent written and spoken English communication skills • Proficiency in MS Office applications • Strong organizational and time management skills

Relevant educational background includes: BSc Life Sciences, MSc Life Sciences, Pharmacy, Clinical Research, Biotechnology, Microbiology, Biochemistry, Pharmacology

Preferred qualifications:

• Master’s degree or PhD in Life Sciences or related disciplines • Prior experience in regulatory medical writing or drug safety • Exposure to global regulatory submissions

Location

Job Location: Mumbai

Application Process

Interested candidates can apply directly through the official Fortrea careers portal using the link below:

Apply Online: https://fortrea.wd1.myworkdayjobs.com/Fortrea/job/Mumbai/Safety-Writer_26219

Shortlisted candidates will be contacted by the recruitment team for further steps in the hiring process.

Frequently Asked Questions

Is this role suitable for freshers?

No. This role requires prior experience in the pharmaceutical industry or medical writing.

What type of reports will the Safety Writer prepare?

The role involves PSURs, PADERs, DSURs, RMPs, annual reports, and other global safety documents.

Does this role involve client interaction?

Yes. The role includes direct communication with internal and external clients.

Is travel required?

Minimal travel is required, up to 5 percent based on project needs.

Is this a permanent position?

Yes. This is a full-time role with long-term career prospects.

Category	Details
Company	Fortrea
Vacancies	Safety Writer
Required Education	BSc Life Sciences, MSc Life Sciences, Pharmacy
Experience	2–3 Years

Tagged as: Pharma Jobs in Mumbai