Bristol Myers Squibb (BMS), one of the world’s leading biopharmaceutical companies, has announced openings for the position of Safety Narrative Writer in Hyderabad, Telangana, India. This is an excellent opportunity for professionals with experience in pharmacovigilance, clinical documentation, medical writing, and clinical data analysis.
The Safety Narrative Writer role involves developing and managing patient safety narratives, supporting clinical study documentation, and ensuring compliance with global regulatory standards, including FDA and ICH guidelines.
Job Details
- Position: Safety Narrative Writer
- Company: Bristol Myers Squibb (BMS)
- Location: Hyderabad, Telangana, India
- Job Type: Full-Time
- Experience Required: 2-5 Years
- Industry: Pharmaceuticals, Biotechnology, Clinical Research
- Job Requisition ID: R1603667
- Work Model: Hybrid (Site-by-Design)
Key Responsibilities
The selected candidate will be responsible for:
- Writing, editing, reviewing, and finalizing Clinical Study Report (CSR) patient safety narratives.
- Serving as the primary point of contact for narrative writing activities within assigned studies.
- Preparing accurate and medically coherent narratives using Clinical Database and Safety Database outputs.
- Conducting quality control checks, compilation, formatting, and finalization of narratives.
- Managing narrative deliverables and timelines efficiently.
- Addressing and resolving narrative-related issues throughout study execution.
- Participating in process improvement initiatives related to patient safety narrative development.
- Collaborating with cross-functional teams in a matrix work environment.
Eligibility Criteria
Educational Qualifications
Candidates should possess any of the following:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Bachelor’s or Master’s Degree in Biomedical Sciences
- Other equivalent Life Sciences degrees
Experience Required
- Minimum 2-5 years of experience in clinical documentation, pharmacovigilance, medical writing, or clinical data management.
- Prior experience in pharmaceutical companies, biotechnology organizations, or Contract Research Organizations (CROs).
Required Skills
Candidates should demonstrate:
- Knowledge of FDA and ICH drug development guidelines.
- Understanding of electronic Common Technical Document (eCTD) requirements.
- Strong medical writing and narrative preparation skills.
- Ability to summarize complex medical information accurately and concisely.
- Experience with document management systems and PDF annotation tools.
- Excellent organizational, communication, and facilitation abilities.
- Strong attention to detail and quality compliance mindset.
- Ability to work effectively with global cross-functional teams.
Why Join Bristol Myers Squibb?
Bristol Myers Squibb offers an environment where employees contribute to life-changing scientific innovations while advancing their careers.
Employee Benefits
- Competitive compensation package
- Flexible and hybrid work environment
- Career growth and learning opportunities
- Exposure to global clinical development projects
- Inclusive and diverse workplace culture
- Comprehensive employee wellness programs
- Opportunities to work on transformational medicines and therapies
How to Apply
