Fortrea Hiring For Safety Writer For Mumbai Location
Company Overview:
Fortrea is a leading global contract research organization (CRO) transforming drug and device development for pharmaceutical, biotechnology, and medical device customers. With over 19,000 staff in more than 90 countries, Fortrea offers clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Position Details:
- Position Name: Safety Writer
- Organization: Fortrea
- Location: Mumbai
- Salary: ₹25,000 – ₹35,000 / month
- Experience: 1 to 2 Years
- Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Key Responsibilities:
| Task | Description |
|---|---|
| Report Writing | Author safety reports for global regulatory submissions including Annual Reports, Periodic Safety Update Reports, Development Safety Update Reports, Risk Management Plans, and other documents. |
| Quality Review | Perform quality reviews of safety reports prepared by junior or associate medical writers. |
| Technical Documents | Write Common Technical Document Summaries, including Non-Clinical and Clinical Overviews and Clinical Summaries. |
| Medical Information | Prepare medical information responses for healthcare professionals. |
| Signal Reports | Author/contribute to signal reports and safety issue analysis reports. |
| Narratives | Write subject narratives for adverse drug reactions and serious adverse events. |
| Communication | Facilitate internal and external (client) communication and coordination for required inputs. |
| Label Updates | Participate in creating and updating labels, including Core Data Sheets, USPI, centralized SPCs, and Med Guides. |
| Literature Searches | Conduct literature searches for authoring reports and routine surveillance activities. Review and propose updates to search strategies. |
| Quality Processes | Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures. |
| Compliance | Ensure compliance with governing regulatory requirements. |
| Customer Service | Create, maintain, and assume accountability for a culture of high customer service. |
| Additional Activities | Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training. |
Qualifications:
- Relevant experience in writing safety reports and regulatory documents.
- Strong organizational and project management skills.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a team environment.
- Proficiency in literature search and review methodologies.
- Knowledge of global regulatory requirements and guidelines.