Senior Safety Writer

2-8 years

Not Disclosed

Mumbai

10 May 24, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Senior Safety Writer

Company Overview: Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with comprehensive clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff operating in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Responsibilities:

Write and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.
Author and review Risk Management Plans, adhoc reports, and medical device reports.
Prepare Common Technical Document Summaries including Non-Clinical and Clinical Overviews.
Conduct trainings for peers and junior team members, providing shadowing opportunities and hands-on experience.
Draft responses to health authority questions or feedback and collaborate with cross-functional stakeholders in managing and tracking such feedback.
Author or review manuscripts, abstracts, and posters for conferences.
Prepare medical information responses for Healthcare Professionals (HCPs).
Perform and review signal detection activities and participate in signal review meetings with clients.
Act as a writing coach and devise training programs.
Author or review Standard Operating Procedures (SOPs), Work Instructions (WIs), and process documents.
Coordinate report writing activities across a team of writers if applicable.
Assist in resource estimation and responding to Requests for Proposals (RFPs).
Communicate internally and externally to obtain required inputs.
Create and update labels and review label changes, authoring proposed label text.
Conduct literature searches and reviews for various reports and routine surveillance.
Perform additional activities as per project requirements or manager’s discretion.
Ensure compliance with regulatory requirements and maintain a culture of high customer service.

Qualifications:

Bachelor’s degree in a relevant field.
Previous experience in safety writing or related roles.
Strong communication and organizational skills.
Ability to work effectively in a collaborative team environment.
Attention to detail and ability to manage multiple tasks simultaneously.

Company Culture: Fortrea fosters a collaborative workspace where personal growth is nurtured, enabling employees to make meaningful global impacts. We encourage diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. As an Equal Opportunity Employer, we make employment decisions based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, sexual orientation, age, disability, or any other legally protected characteristic. We welcome all applicants to apply and join our exceptional team. For more information about Fortrea, visit www.fortrea.com.

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Senior Safety Writer

Job Description

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