Senior Safety Writer Project Coordinator Job at Fortrea with pharmacovigilance, aggregate safety reporting, regulatory writing experience.
Company: Fortrea
Job Title: Senior Safety Writer and Project Coordinator
Location: Mumbai, Maharashtra, India
Work Mode: Hybrid
Employment Type: Full-Time, Permanent
Experience Required: 5–7 Years
Application Deadline: January 29, 2026
Job Requisition ID: 26116
About the Company
Fortrea is a leading global contract research organization (CRO) providing clinical development and post-marketing services to the pharmaceutical, biotechnology, and medical device industries. With deep scientific expertise and a strong global presence, Fortrea supports sponsors across the full drug development lifecycle, from early-phase research to post-approval safety and regulatory submissions. Senior Safety Writer Project Coordinator Job
The organization is known for its high-quality scientific writing, regulatory compliance, and pharmacovigilance services. Fortrea fosters a collaborative, quality-driven environment where professionals are encouraged to apply scientific rigor, innovation, and efficiency to deliver impactful healthcare solutions.
Joining Fortrea means becoming part of a global team dedicated to improving patient safety and supporting regulatory excellence worldwide. Senior Safety Writer Project Coordinator Job
Job Details
- Job Title: Senior Safety Writer and Project Coordinator
- Location: Mumbai, Maharashtra, India
- Work Model: Hybrid
- Employment Type: Full-Time
- Industry: Pharmacovigilance / Medical Writing / Clinical Research
- Experience Level: Senior
- Travel Requirement: Up to 10%
This role combines advanced safety writing responsibilities with project coordination and client-facing activities in a global regulatory environment.
Job Description
The Senior Safety Writer and Project Coordinator will lead the preparation, review, and submission of aggregate safety reports, risk management documents, and benefit-risk evaluations for global regulatory submissions. The role involves end-to-end management of safety writing deliverables, including planning, authoring, review coordination, quality checks, and timely submission.
The position requires applying in-depth pharmacovigilance knowledge, regulatory expertise, and strong project management skills to manage complex deliverables. The selected candidate will coordinate multiple safety writing activities across teams, liaise with internal and external stakeholders, and ensure high-quality, compliant documentation is delivered on time. Senior Safety Writer Project Coordinator Job
This role is ideal for experienced safety writers seeking leadership responsibilities, client interaction, and exposure to global regulatory submissions. Senior Safety Writer Project Coordinator Job
Key Responsibilities
As a Senior Safety Writer and Project Coordinator, your responsibilities will include: Senior Safety Writer Project Coordinator Job
- Leading the preparation and review of aggregate safety reports, risk management plans, signal detection documents, and benefit-risk evaluation reports
- Managing end-to-end report delivery including planning, authoring, review, approval, and submission activities
- Ensuring timely delivery of high-quality, compliant documents to internal stakeholders and external sponsors
- Coordinating safety writing activities across a team of writers, including task allocation and schedule oversight
- Writing and reviewing global regulatory safety documents including:
- Annual Reports (IND and other regional equivalents)
- Periodic Safety Update Reports (PSUR)
- Periodic Benefit-Risk Evaluation Reports (PBRER)
- Periodic Adverse Drug Experience Reports (PADER)
- Development Safety Update Reports (DSUR)
- Bridging reports and ad hoc safety reports
- Authoring Common Technical Document (CTD) summaries such as Non-Clinical Overviews, Clinical Overviews, and Clinical Summaries
- Authoring and reviewing Risk Management Plans (RMPs), Safety Update Reports, Addendum Reports, and supporting documentation
- Preparing medical information responses for healthcare professionals
- Acting as a writing coach and mentor to junior safety and medical writers
- Generating and reviewing line listings, summary tabulations, CFIs, and CFCs
- Serving as the primary point of contact for clients on safety writing deliverables
- Managing internal and external communication to obtain required inputs and resolve issues affecting timelines
- Performing quality checks, tracking deliverables, and maintaining project metrics
- Assisting in resource estimation and responding to Requests for Proposals (RFPs)
- Supporting preparation and updates of product labels including Core Data Sheets, US Prescribing Information, Summary of Product Characteristics, and Medication Guides
- Conducting literature searches to support safety assessments and labeling updates
- Ensuring compliance with regulatory requirements, SOPs, and pharmacovigilance standards
- Supporting continuous improvement initiatives for writing quality and process efficiency
- Performing additional responsibilities as required by project needs or management
Senior Safety Writer Project Coordinator Job
Required Qualifications
Educational Qualification
- Minimum of a Bachelor’s degree in Life Sciences or an equivalent discipline
- Equivalent relevant experience may be considered in place of formal education
Experience Requirements
- 5–7 years of experience in the pharmaceutical industry, or
- Minimum 4 years of experience in medical or safety writing
- Experience in pharmacovigilance and drug safety is strongly preferred
- Experience in global regulatory submissions is required
Senior Safety Writer Project Coordinator Job
Skills and Competencies
- Excellent command of written and spoken English
- Strong medical and scientific writing skills
- Good understanding of global regulatory requirements
- Knowledge of pharmacovigilance practices and ICH GCP guidelines
- Thorough understanding of benefit-risk assessment and drug safety evaluation
- Strong knowledge of anatomy, physiology, disease states, and medical treatments
- Proficiency in MS Office applications
- Excellent organizational and time management skills
- Strong interpersonal and stakeholder management abilities
- Ability to manage multiple projects and priorities simultaneously
- Scientific or clinical research experience is desirable
Senior Safety Writer Project Coordinator Job
Preferred Qualifications
- Advanced degree such as a Master’s or PhD in Life Sciences, Pharmacy, or related discipline
Work Environment and Travel
- Hybrid work model with office-based and home-based work
- Occasional travel up to 10%, including overnight stays, depending on project requirements
Why You Should Join Fortrea
Fortrea offers a dynamic environment where experienced safety writers can grow into leadership and coordination roles while working on high-impact global regulatory projects. You will gain exposure to complex safety documentation, global clients, and evolving regulatory landscapes.
The organization values quality, accountability, and collaboration, providing professionals with opportunities for continuous learning, skill enhancement, and career advancement in pharmacovigilance and medical writing. Senior Safety Writer Project Coordinator Job
FAQs
Is this a full-time position?
Yes, this is a full-time role.
Is the role remote or office-based?
This is a hybrid role based in Mumbai.
What type of reports will I work on?
You will work on aggregate safety reports, risk management plans, benefit-risk evaluations, and regulatory submissions.
Is client interaction involved?
Yes, the role includes direct communication with internal and external clients.
What is the application deadline?
The deadline to apply is January 29, 2026.
How to Apply
Interested candidates should apply online through the official Fortrea careers portal by uploading their updated resume and completing the application process before the deadline. Senior Safety Writer Project Coordinator Job
Only shortlisted candidates will be contacted for further selection steps.
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