Safety Narrative Writer

2-4 years

Not Disclosed

Hyderabad

10 July 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Working with Us at Bristol Myers Squibb

Overview:

Challenging. Meaningful. Life-changing. At Bristol Myers Squibb, we redefine what a job can be. Here, unique and impactful work happens daily in every department. From optimizing production lines to breakthroughs in cell therapy, our work transforms patient lives and the careers of those involved. Join us to grow and thrive through unparalleled opportunities alongside high-achieving, diverse teams.

Balance and Flexibility:

We recognize the importance of work-life balance and flexibility. Our competitive benefits, services, and programs provide resources for employees to achieve their goals at work and in their personal lives.

Key Responsibilities:

Clinical Study Report (CSR) Narratives:
- Write, edit, review, finalize, and track CSR patient safety narratives.
- Serve as the primary contact for narrative writing for assigned studies, managing timelines and resolving narrative-related issues.
- Prepare clear and accurate narratives based on Clinical Database and Safety Database outputs, ensuring medical cohesiveness.
- Ensure high-quality work through final quality control checks, compilation, and formatting.
- Participate in process improvement activities for developing patient safety narratives.

Qualifications & Experience:

Education:
- Bachelor’s/Master’s degree in biomedical or life sciences fields.
Experience:
- 2-4 years of experience in clinical documentation and data.
- Prior experience in pharmaceuticals, biotechnology, or contract research organizations.
Knowledge:
- Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process.
- Understanding of electronic Common Technical Document (eCTD) requirements.
- Ability to create concise, accurate, and relevant synopses of medical text and data.
- Familiarity with electronic document management systems and PDF annotation tools.
Skills:
- Strong organizational, communication, and facilitation skills for managing timelines and work quality.
- Effective interpersonal skills for working in a matrix team environment and with colleagues at all levels.

Why You Should Apply:

At Bristol Myers Squibb, we are dedicated to making an impact on patients with serious diseases. Empowered by our inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion, and integrity help us reach our highest potential. We offer competitive benefits and resources to support your goals both professionally and personally.

Working at BMS:

Uniquely Interesting Work, Life-changing Careers:
- With the vision "Transforming patients’ lives through science™," each BMS employee plays a vital role in extraordinary work. Our inclusive culture and diverse clinical trials promote passion, innovation, and accountability.

On-site Protocol:

BMS has diverse occupancy structures based on the nature and responsibilities of roles:
- Site-essential roles require 100% onsite presence.
- Site-by-design roles may be eligible for a hybrid model with at least 50% onsite presence.
- Field-based and remote-by-design roles require physical travel for meetings and customer interactions as essential functions.

Accessibility and Inclusion:

BMS ensures people with disabilities excel through a transparent recruitment process, reasonable accommodations, and ongoing support. Applicants can request accommodations during the recruitment process by contacting adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our complete Equal Employment Opportunity statement.

Well-being and Vaccination Policy:

BMS prioritizes the well-being of our staff, customers, patients, and communities. We recommend all employees be fully vaccinated for Covid-19 and stay up to date with boosters.

Equal Opportunity Employer:

BMS is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, or any other protected class. We consider qualified applicants with arrest and conviction records, per applicable laws.

Data Privacy:

Any data processed in connection with role applications will be treated per applicable data privacy policies and regulations.

Explore Careers:

If intrigued by a role, even if it doesn’t perfectly align with your resume, we encourage you to apply. You might be one step away from transformative work and a life-changing career. Visit careers.bms.com/working-with-us for more information.

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