Safety Writer Job in Mumbai for experienced pharma professionals in pharmacovigilance, regulatory writing, and global safety documentation roles.
Company Overview
Fortrea is a global organization operating in the pharmaceutical and life sciences domain, supporting drug development, regulatory compliance, and patient safety initiatives. The company works closely with international sponsors, regulatory authorities, and healthcare stakeholders to ensure medicines meet global safety and quality standards. With a strong focus on pharmacovigilance, regulatory documentation, and scientific integrity, Fortrea provides professionals the opportunity to work on complex global projects while collaborating with multidisciplinary teams across regions. Safety Writer Job in Mumbai
Job Location & Employment Type
- Job Location: Mumbai, Maharashtra
- Employment Type: Full-time, permanent role
- Work Model: Office-based / hybrid depending on project requirements
Open Positions / Department Details
- Position Title: Safety Writer
- Department: Drug Safety & Pharmacovigilance / Medical Writing
- Number of Openings: Not disclosed
- Reporting To: Senior Safety Writing or Pharmacovigilance Leadership
This position is designed for experienced medical and safety writers who are looking to strengthen their career in aggregate safety reporting and regulatory documentation. Safety Writer Job in Mumbai
Key Roles & Responsibilities
The Safety Writer will play a critical role in the preparation, review, and finalization of global safety and regulatory documents. Key responsibilities include but are not limited to: Safety Writer Job in Mumbai
- Authoring comprehensive aggregate safety reports required for international regulatory submissions, including periodic and annual safety updates.
- Developing risk management documents that support benefit–risk evaluations for medicinal products across their lifecycle.
- Coordinating report development activities such as data gathering, document planning, internal review cycles, and resolution of stakeholder comments.
- Performing scientific and editorial review of safety documents prepared by junior writers to ensure regulatory accuracy, consistency, and clarity.
- Supporting preparation of clinical and non-clinical summaries required for regulatory dossiers and CTD submissions.
- Drafting adverse event narratives based on clinical and post-marketing safety data.
- Preparing medical information responses for healthcare professionals and regulatory authorities.
- Assisting in signal evaluation activities and contributing to safety issue analysis documentation.
- Conducting structured literature searches using approved databases and summarizing safety-relevant findings.
- Working closely with pharmacovigilance, clinical, regulatory affairs, and data management teams to ensure timely submission of high-quality documents.
- Ensuring all deliverables comply with international guidelines, pharmacovigilance standards, and internal quality procedures.
- Maintaining accurate documentation records and adhering to project timelines under minimal supervision.
Safety Writer Job in Mumbai
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences, Pharmacy, or a related scientific discipline.
- Candidates with higher qualifications such as M.Pharm, M.Sc, Pharm.D, or Ph.D will be given preference.
Experience
- Minimum 3 years of experience in the pharmaceutical or life sciences industry.
- At least 2 years of hands-on experience in medical or safety writing is required.
- Prior exposure to pharmacovigilance documentation and regulatory submissions is essential.
Skills Required
- Strong proficiency in written and spoken English with the ability to present complex scientific information clearly.
- Sound understanding of drug safety, aggregate reporting, and pharmacovigilance processes.
- Working knowledge of international regulatory guidelines and documentation standards.
- Ability to manage multiple projects simultaneously while meeting strict deadlines.
- Excellent attention to detail and strong quality-review skills.
- Proficiency in MS Office applications, including Word, Excel, and PowerPoint.
- Strong communication and collaboration skills for working with global cross-functional teams.
Safety Writer Job in Mumbai
Salary & Benefits
- Salary: As per company norms
- Additional benefits may include professional development opportunities, structured training programs, and exposure to global regulatory projects.
- Limited travel requirements (up to 5%), depending on project needs.
Selection Process
The selection process may include:
- Application screening by the recruitment team
- Technical interview focusing on safety writing and pharmacovigilance knowledge
- Final discussion with hiring managers or project leads
Only shortlisted candidates will be contacted for further rounds.
How to Apply
- Mode of Application: Online application only
- Interested candidates should apply through the official application link provided by the employer.
Important Dates
- Job Posted On: February 3, 2026
- Last Date to Apply: Not specified (apply as early as possible)
Why Apply for This Pharma Job?
This opportunity is ideal for professionals seeking long-term growth in safety writing and pharmacovigilance. The role offers exposure to global regulatory submissions, complex safety documentation, and collaboration with experienced international teams. Working in this position allows candidates to enhance their scientific writing expertise while contributing directly to patient safety and regulatory compliance. For professionals aiming to build a stable and impactful career in pharmaceutical safety, this role provides both learning and advancement opportunities. Safety Writer Job in Mumbai
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform. We are not directly affiliated with Fortrea or any other company. Job details are shared for informational purposes only. Candidates are advised to verify all information and apply through official company channels. Safety Writer Job in Mumbai
Final Call-to-Action
Qualified and motivated safety writing professionals are encouraged to apply promptly and take the next step in their pharmaceutical career. Safety Writer Job in Mumbai
