Senior Safety Writer

3 weeks ago

Mumbai, India Fortrea Full time

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. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

 Write and review various safety reports (or part of such reports) for global regulatory submissions,
including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic
Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Development Safety
Update Report, ACOs, Addendum reports, as assigned.
 Author and review RMPs, adhoc reports, Benefit-Risk Evaluation reports, medical device reports.
 Write 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, provide shadowing opportunities and hands-on
experience.
 Draft responses (or parts thereof) to health authority questions or feedback and collaborate with crossfunctional
stakeholders in the management and tracking of such feedback.
 Author/review manuscripts, abstracts, posters for conferences.
 Prepare medical information responses for HCPs.
 Perform/review signal detection activities. Participate in preparing signaling strategy signal/safety
review meetings with clients and help gather safety data for signal evaluation by conducting searches
in the safety database, published literature, external databases, etc.
 Author signal reports (ad hoc & periodic) & safety issue analysis reports.
 Act as a writing coach, devise training programs.
 Author/review SOPs/WIs/process documents or sections as applicable.

 Coordinate activities related to various types of report writing across a team of writers if applicable.
 Perform various support activities such as tracking, maintenance of metrics, performing and
documenting quality checks and training.
 Assist in estimation of resource requirement and responding to RFPs as needed.
 Internal and external (client) communication & co-ordination to get the required inputs.

 Get resolution on issues affecting project deliverables.
 Create and update labels e.g. Core Data Sheets, USPI, centralized SPC’s, Med Guides. Review and
recommend label changes, author proposed label text and prepare supporting/justification document.
 Conduct literature searches and review for authoring various types of reports and routine surveillance.
Review the articles selected by medical writers/junior staff, discuss conflicting review opinions with
the safety physician.
 Perform any additional activities as per the project requirement or manager’s discretion.
 Implement and promote use of consistent, efficient, and quality processes to meet timelines and
deliverables according to requirements and standard operating procedures, and assume accountability
for the deliverables.
 Ensure compliance of operations with governing regulatory requirements.
 Create, maintain, and assume accountability for a culture of high customer service.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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