Principal Safety Writer

5-7 years

Not Disclosed

Mumbai

10 Feb. 17, 2025

Job Description

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

Principal Safety Writer

Location: Mumbai, India
Category: Clinical
Job ID: 2447515

Job Overview:

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. Conducting operations in ~100 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

The Principal Safety Writer will lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports. This role involves independently managing safety deliverables, collaborating with internal and external stakeholders, and contributing to scientific publications and conferences.

Summary of Responsibilities:

Write and review various safety reports for global regulatory submissions, including but not limited to Annual Reports, Periodic Safety Update Reports (PSUR), Periodic Adverse Drug Experience Reports (PADER), Development Safety Update Reports (DSUR), Clinical Overviews, and Medical Device reports.
Lead the end-to-end process of report production, ensuring quality standards and key timelines are met.
Act as the primary point of contact for clients regarding report management activities.
Author and review Risk Management Plans (RMPs), benefit-risk evaluation reports, supporting documents for label updates, and reports on the effectiveness of risk minimization measures.
Lead and participate in signal detection and management processes, develop signal strategies, and author signal evaluation/management reports.
Participate in safety/benefit-risk review meetings, discuss signal analysis results, and propose risk mitigation measures in collaboration with safety physicians.
Draft responses to health authority questions and collaborate with cross-functional stakeholders to manage regulatory feedback.
Develop abstracts, posters, manuscripts, and other scientific publications for conferences and forums.
Act as a writing coach, provide quality feedback, conduct training, and share best practices with associates.
Support project management activities, including schedule maintenance and metric tracking.
Contribute to business development activities, including estimating resource requirements and responding to RFPs.
Create and update regulatory labels, including Core Data Sheets, USPI, and SPCs.
Conduct literature reviews, formulate search strategies, and execute complex research queries.
Ensure compliance with regulatory requirements and good pharmacovigilance practices.

Qualifications (Minimum Requirements):

Bachelor’s degree in Life Sciences or equivalent (advanced degree preferred).
5-7 years of experience in the pharmaceutical industry, with at least 4 years in medical writing.
Strong understanding of regulatory requirements, good pharmacovigilance practices, and ICH GCP guidelines.
Extensive knowledge of regulatory submissions for US, EU, and emerging markets.
Excellent command of written and spoken English.
Strong organizational and time management skills.
Ability to work independently and mentor junior team members.
Proficiency in MS Office.

Preferred Qualifications:

Advanced degree (PhD, Master’s) in a relevant field.
Experience in drug discovery and pharmacovigilance.
Strong leadership and interpersonal skills.

Work Environment:

Office-based or remote work available.
Travel required up to 15% of the time, including overnight stays.

Why Join Fortrea?

Fortrea is actively seeking motivated problem-solvers and creative thinkers to revolutionize clinical trials and drug development. Join us in our mission to deliver life-changing therapies to patients worldwide.

Equal Opportunity Employer Statement:

Fortrea is committed to diversity and inclusion. We do not discriminate based on race, religion, gender, sexual orientation, age, disability, or any other legally protected characteristic.

For more details, visit www.fortrea.com.

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Principal Safety Writer

Job Description

Job Overview:

Summary of Responsibilities:

Qualifications (Minimum Requirements):

Preferred Qualifications:

Work Environment:

Why Join Fortrea?

Equal Opportunity Employer Statement:

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