Job Title: Safety Writer
Location: Mumbai
Category: Clinical
Job ID: 2443863
Company Overview:
Fortrea is a leading global contract research organization (CRO), specializing in providing clinical development, patient access, and technology solutions to the pharmaceutical, biotechnology, and medical device industries. With operations in approximately 100 countries, Fortrea is at the forefront of transforming drug and device development, contributing to the global health landscape.
Job Overview:
As a Safety Writer, you will play a key role in creating and reviewing safety-related reports for global regulatory submissions. This includes authoring and reviewing documents such as Periodic Safety Update Reports, Risk Management Plans, and other safety reports. You will collaborate with internal teams and clients to ensure the quality and timeliness of report delivery, taking ownership of your assigned deliverables.
Key Responsibilities:
Report Writing and Ownership:
Write and/or contribute to global safety reports including Annual Reports, Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans, and others.
Take ownership of assigned deliverables, coordinating with stakeholders to gather necessary inputs and ensuring timely completion.
Leadership and Collaboration:
Lead and facilitate meetings such as kick-off sessions and roundtable discussions for comment resolution.
Perform quality reviews of safety reports authored by junior or associate medical writers.
Ad-hoc Reports and Support:
Author or contribute to additional safety-related reports, such as benefit-risk evaluation reports and supporting documents for label updates.
Client and Stakeholder Management:
Work closely with internal teams and external clients to ensure alignment on deliverables and expectations.
Qualifications:
Education:
A degree in life sciences or related field. Equivalent experience may be considered in lieu of educational qualifications.
Experience:
Prior experience in the pharmaceutical or clinical research industry, particularly in medical writing or safety reporting.
Experience in writing and reviewing safety reports for regulatory submissions is highly desirable.
Skills:
Strong written and verbal communication skills in English.
Ability to manage multiple tasks, prioritize, and collaborate effectively in a team-oriented environment.
Familiarity with regulatory guidelines and safety practices in clinical trials.
Fortrea’s Culture:
Fortrea is committed to creating an environment where personal growth and collaboration thrive. Their Fortrea FOUR culture encourages employees to act Forward Together, Own It, Uphold Integrity, and Respect People, making a meaningful global impact.
Equal Opportunity Employer:
Fortrea is proud to be an equal opportunity employer, committed to diversity and inclusion in the workplace. They do not tolerate harassment or discrimination and ensure employment decisions are made based on qualifications and the needs of the business.
This is an exciting opportunity for someone with a passion for safety reporting and regulatory submissions. If you are interested, let me know if you would like more details about the role or application process!
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