Safety Writer

0-3 years

Not Disclosed

Mumbai

10 May 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Safety Writer

Company: Fortrea

Experience: 0-3 years

Location: Mumbai

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

Job Description:

Responsibilities:

Perform data collection for report planning, develop strategy, and lead kick-off meetings and round table discussions for comment resolution.
Write various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Development Safety Update Report, Risk Management Plans, etc.
Perform quality review of safety reports prepared by junior or associate medical writers.
Author or contribute to ad hoc reports, benefit-risk evaluation reports, and supporting documents for label updates.
Write Common Technical Document Summaries including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned.
Prepare medical information responses for Healthcare Professionals (HCPs).
Author/contribute to signal reports and safety issue analysis reports.
Write subject narratives for adverse drug reactions and serious adverse events.
Coordinate with internal and external stakeholders to gather required inputs.
Participate in creating and updating labels, such as Core Data Sheets, USPI, centralized SPCs, Med Guides.
Conduct literature searches and review selected articles for various reports or routine surveillance activities. Author literature abstracts/summaries and propose Company comments.
Ensure compliance with regulatory requirements and promote efficient processes to meet timelines and deliverables.
Foster a culture of high customer service and collaboration within the team.
Perform additional activities as per project requirements or manager's discretion upon completion of relevant training.

Qualifications:

Bachelor's degree in a relevant field.
Excellent communication skills and attention to detail.
Ability to work independently and in a team environment.
Strong analytical and problem-solving skills.
Familiarity with regulatory requirements and guidelines.
0-3 years of relevant experience.

Join Fortrea and be part of a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. Visit www.fortrea.com for more information.

Fortrea is proud to be an Equal Opportunity Employer: We value diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender, family status, marital status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. All are encouraged to apply.

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Safety Writer

Job Description

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