Principal Safety Writer

4-7 years

Not Disclosed

Mumbai

10 Jan. 28, 2025

Job Description

Job Type: Remote Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Principal Safety Writer

Location: Mumbai
Category: Clinical
Job ID: 2447515

About Fortrea

Fortrea is a global contract research organization (CRO) dedicated to scientific rigor and clinical development. Supporting pharmaceutical, biotechnology, and medical device clients, Fortrea offers clinical development, patient access, and technology solutions across 20+ therapeutic areas. Operating in nearly 100 countries, Fortrea strives to transform drug and device development for global partners and patients.

Job Overview

The Principal Safety Writer will lead the preparation and review of aggregate safety reports, risk management documents, signal detection analyses, and benefit-risk evaluation reports. The role requires independent management of complex safety deliverables, acting as a technical lead, and providing guidance to writing teams. The role also involves fostering strong client relationships and contributing to scientific publications and quality improvement initiatives.

Key Responsibilities

Safety Document Preparation and Oversight

Author and review safety reports for global regulatory submissions, including:
- Annual Reports (IND and others)
- Periodic Safety Update Reports (PSUR)
- Periodic Adverse Drug Experience Reports (PADER)
- Development Safety Update Reports (DSUR)
- Risk Management Plans (RMPs)
- Clinical Overviews and Medical Device Reports
Ensure end-to-end management of report production, meeting quality standards and timelines.
Oversee and provide guidance to team members contributing to report writing.

Signal Management and Safety Analysis

Lead and participate in signal management processes, including data retrieval, signal evaluation, and safety issue analysis.
Prepare and review signal management and benefit-risk evaluation reports.
Collaborate with clients and safety physicians to propose label updates and risk mitigation measures.

Client and Stakeholder Engagement

Act as the primary point of contact for clients regarding report management activities.
Communicate effectively with clients to manage expectations, resolve challenges, and ensure timely deliverables.

Scientific Contribution

Draft abstracts, posters, manuscripts, and other scientific publications.
Prepare medical information responses for healthcare professionals.
Represent the company at scientific meetings and conferences.

Training and Mentorship

Provide coaching, training, and feedback to team members to promote high-quality scientific writing.
Share best practices and ensure adherence to style guides and quality standards.

Project Management and Compliance

Support project management by maintaining schedules, tracking metrics, and ensuring compliance with regulatory requirements.
Contribute to business development activities, including resource estimation and responding to RFPs.

Qualifications

Minimum Requirements

Bachelor's degree in life sciences or equivalent (relevant experience may substitute).
5-7 years of experience in the pharmaceutical industry, with at least 4 years in medical writing.
Strong command of written and spoken English.
Proficient in MS Office and organizational/time management skills.
Excellent interpersonal, communication, and leadership skills.
Knowledge of regulatory requirements, ICH GCP guidelines, and good pharmacovigilance practices.
Understanding of the pharmaceutical product development cycle and regulatory submissions for US, EU, and emerging markets.

Preferred Qualifications

Advanced degree (e.g., PhD or Master's).
Experience in drug discovery and pharmacovigilance.

Work Environment and Travel

Office-based or remote.
Availability to travel up to 15% of the time, including overnight stays, depending on project needs.

Equal Opportunity Employer

Fortrea is an Equal Opportunity Employer (EOE/AA) committed to diversity and inclusion. Employment decisions are made without discrimination based on legally protected characteristics.

For reasonable accommodation requests, contact taaccommodationsrequest@fortrea.com.

For more information, visit www.fortrea.com.

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