[Freshers] Fortrea Hiring Regulatory Safety Writer in Pune
Position: Safety Writer
Organization: Fortrea
Type: Full-time
Location: Pune
Salary: ₹4L – ₹5L/yr
About Us:
Fortrea is a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience. We provide 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 operating in more than 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.
Qualifications:
| Requirement | Details |
|---|---|
| Education | B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences |
| Experience | 0 years / Freshers – 1 year |
| Skills | Motivated problem-solvers, creative thinkers, commitment to innovation |
Key Responsibilities:
- Implement and promote efficient, quality processes to meet timelines and deliverables.
- Ensure compliance with regulatory requirements.
- Create and maintain a culture of high customer service.
- Conduct literature searches and author various types of safety reports.
- Author/review global regulatory submissions, including Annual Reports, PSURs, PADERs, PBRERs, Bridging reports, etc.
- Perform/review Signal detection activities.
- Author/review RMP, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting documents, etc.
- Perform allied activities like generation of line listings and summary tabulation.
- Search literature databases, recommend label changes, author proposed label text, and prepare supporting documents.
- Author/review SOPs/WIs/process documents as applicable.
- Conduct training sessions for peers and team members.
- Perform additional activities as required.
How to Apply:
Submit your resume and cover letter to [contact email].