Safety Narrative Writer

Hyderabad, INPosted Jul 3, 2026
Career Areas Career Stories Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Careers Home Life at BMS Career Areas Student Opportunities Events How We Recruit Career Stories Search this site Join Talent Community Candidate Login English English Italiano Español Français Português Norsk Deutsch 日本語 Bahasa melayu 中文 (简体) 中文 (繁體) 한국어 ภาษาไทย Nederlands Polski Yкраїнська Hrvatski Ελληνικά Magyar čeština Türkçe Pусский Haitian עברית Brazilian Português Dansk Suomi Svenska Français (Canada) Português (Portugal) Single PositionView All JobsSafety Narrative WriterHyderabad - TS - IN No longer accepting applications.Job IDR1603667Date posted06/17/2026DepartmentNot ApplicableDuties/Responsibilities Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narrativesServes as primary contact for narrative writing for an assigned study, deliverable timelines, and addressing/resolving any narratives related issues (as required)Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesivenessEnsures the work is complete and of high quality, including final quality control checks, compilation and formatting.Participates in process improvement activities to develop patient safety narratives.Reporting Relationship Senior Manager, Clinical Study Narrative ProductionQualificationsCollege or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fieldsMinimum 2-5 years of experience working with clinical documentation and dataPrior pharmaceutical, biotechnology, or contract research organization experienceBasic knowledge of global regulations and guidelines (FDA, ICH) on the drug development processBasic knowledge of electronic Common Technical Document (eCTD) requirementsDemonstrated capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical textWorking knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews.Ability to manage timelines and quality of work using strong organizational, communication, and facilitation skills.Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.Duties/Responsibilities Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narrativesServes as primary contact for narrative writing for an assigned study, deliverable timelines, and addressing/resolving any narratives related issues (as required)Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesivenessEnsures the work is complete and of high quality, including final quality control checks, compilation and formatting.Participates in process improvement activities to develop patient safety narratives.Reporting Relationship Senior Manager, Clinical Study Narrative ProductionQualificationsCollege or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fieldsMinimum 2-5 years of experience working with clinical documentation and dataPrior pharmaceutical, biotechnology, or contract research organization experienceBasic knowledge of global regulations and guidelines (FDA, ICH) on the drug development processBasic knowledge of electronic Common Technical Document (eCTD) requirementsDemonstrated capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical textWorking knowledge of an electronic document management system and PDF annotation tools to...

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