About the Role
The Safety Writing Assistant II will play a key role in pharmacovigilance operations by supporting the development of critical safety documents and regulatory submissions. This position offers an excellent opportunity for early-career professionals to build expertise in drug safety documentation while working alongside experienced medical writers.
Key Responsibilities
Document Preparation & Review
- Draft sections of periodic safety reports (PSURs, PBRERs, DSURs)
- Prepare data summaries, literature abstracts, and case narratives
- Support the development of Risk Management Plans (RMPs)
Regulatory Compliance
- Assist in preparing Clinical/Non-Clinical Overviews for CTD
- Conduct literature searches for safety information
- Ensure compliance with ICH GCP and pharmacovigilance guidelines
Operational Support
- Generate outputs from safety databases
- Participate in comment resolution processes
- Maintain documentation timelines and quality standards
Candidate Profile
Essential Qualifications
- Bachelor’s degree in Pharmacy, Biotechnology, or related life sciences
- 6-12 months experience in pharma/healthcare sector
- Strong scientific writing skills in English
- Proficiency in MS Office (Word, Excel)
Preferred Qualifications
- Master’s degree in relevant discipline
- Understanding of regulatory requirements (GVP, ICH GCP)
- Exposure to clinical research or drug safety
Why Join Fortrea?
- Structured training in pharmacovigilance writing
- Exposure to global safety reporting standards
- Career progression opportunities in medical writing
- Collaborative work environment
How to apply for the Fortrea Safety Writing Job?
Interested candidates should submit:
- Updated CV highlighting relevant experience
- Academic transcripts
- Writing sample (if available)
Note: Final compensation will be determined based on candidate’s qualifications and experience. Some travel (up to 5%) may be required.
Fortrea Safety Writing Job Summary
The Safety Writing Assistant II position at Fortrea is an entry-to-mid-level role ideal for life sciences graduates seeking to launch their career in pharmacovigilance and regulatory writing. This role focuses on supporting the preparation of critical drug safety documents, including periodic safety reports (PSURs, PBRERs), risk management plans (RMPs), and regulatory submissions.
Successful candidates will gain hands-on experience in:
✔ Authoring safety report sections using template-driven content
✔ Conducting literature searches and data summarization
✔ Collaborating with medical writers and safety teams
✔ Ensuring compliance with ICH-GCP and pharmacovigilance guidelines
This position offers a structured pathway for professional growth in drug safety documentation, with opportunities to develop expertise that bridges scientific analysis and regulatory writing. The role is particularly suited for detail-oriented candidates with strong scientific writing skills who thrive in collaborative, deadline-driven environments.
Note: This office-based/hybrid role may require minimal travel (≤5%) for team meetings or training.
Key Highlights
- Career Starter: Ideal first step into pharmacovigilance writing
- Skill Development: Master safety databases and regulatory templates
- Growth Potential: Pathway to Medical Writer/Safety Scientist roles
- Compensation: Competitive package (₹4-6.5 LPA) with benefits
Fortrea values diversity and provides equal employment opportunities to all qualified applicants.
Disclaimer: Salary range is indicative and based on industry standards for similar roles in India.
