Safety Writer – Pharmacovigilance at Fortrea
Position Name:
Safety Writer
Organization:
Fortrea
Qualification:
PharmD, PhD, MD, or equivalent (preferred)
Experience:
1 to 2 Years
Salary:
Not Disclosed
Location:
Mumbai
About Fortrea
Fortrea is a global leader in contract research, providing scientific expertise and clinical development services. With over 19,000 employees in more than 90 countries, Fortrea serves pharmaceutical, biotechnology, and medical device companies across 20+ therapeutic areas. The organization is committed to transforming drug and device development, bringing life-changing therapies to patients worldwide.
Job Responsibilities
As a Safety Writer at Fortrea, you will be responsible for preparing key safety and regulatory documents for global submissions. Your role will include:
- Collecting and organizing data for report planning and strategy development.
- Writing safety reports for regulatory submissions, including: Report Types Description Annual Reports IND and other reports PSUR Periodic Safety Update Reports PADER Periodic Adverse Drug Experience Reports DSUR Development Safety Update Reports RMP Risk Management Plans
- Collaborating with clients and stakeholders to gather input.
- Conducting quality reviews of reports prepared by junior writers.
- Writing subject narratives for adverse drug reactions (ADRs) and serious adverse events (SAEs).
- Contributing to Clinical Summaries and Common Technical Document (CTD) Summaries.
Qualification Requirements
To qualify for the Safety Writer role at Fortrea, candidates must meet the following requirements:
| Qualification | Requirement |
|---|---|
| Degree | PharmD, PhD, MD, or equivalent (preferred) |
| Experience | 1 to 2 years in medical writing and safety report writing |
Skills Required
The ideal candidate should possess the following essential skills:
- Attention to Detail: Ensuring accuracy and quality in safety reports.
- Literature Search: Ability to conduct and analyze literature for report development.
- Communication Skills: Strong written and verbal skills for clear, concise documentation.
- Project Management: Effective handling of multiple deliverables and deadlines.
- Collaboration: Strong interpersonal skills for working with stakeholders and clients.
How to Apply
Interested candidates meeting the qualification criteria can apply via the official Fortrea website or the company’s career portal.
Meta Description:
Fortrea hiring Safety Writer in pharmacovigilance for Mumbai. Apply if you have 1-2 years of experience.