Senior Safety Writer

1-8 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: Senior Safety Writer

Company: Fortrea

Experience: 1-8 years

Location: Mumbai

Company Overview: Fortrea is a leading global contract research organization (CRO) committed to scientific rigor and excellence in clinical development. With decades of experience, we offer pharmaceutical, biotechnology, and medical device companies comprehensive solutions across over 20 therapeutic areas. Our global team of over 19,000 staff operates in more than 90 countries, revolutionizing drug and device development for partners and patients worldwide.

Job Description:

Responsibilities:

Write and review various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Development Safety Update Reports, etc.
Author and review Risk Management Plans, ad hoc reports, Benefit-Risk Evaluation reports, and medical device reports.
Draft Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned.
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 feedback.
Author/review manuscripts, abstracts, and posters for conferences.
Prepare medical information responses for Healthcare Professionals (HCPs).
Perform/review signal detection activities and participate in signal/safety review meetings with clients.
Act as a writing coach, devising training programs, and authoring/reviewing SOPs/WIs/process documents.
Coordinate activities related to report writing across a team of writers if applicable.
Assist in resource estimation and responding to RFPs as needed.
Coordinate internal and external communication to gather required inputs.
Resolve issues affecting project deliverables and ensure compliance with regulatory requirements.
Promote a culture of high customer service and adherence to quality processes.

Qualifications:

Bachelor's degree in a relevant field.
Excellent communication skills and attention to detail.
Experience in writing safety reports and regulatory documents.
Proficiency in SQL, Python, and Core Java preferred.
Ability to mentor junior team members and conduct trainings.
Strong analytical and problem-solving skills.
Familiarity with regulatory requirements and guidelines.
1-8 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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Senior Safety Writer

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