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Safety Writer
Fortrea Development India Private Limited
posted 8hr ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution
- Write 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, Development Safety Update Report, Risk Management Plans, and other documents
- Take ownership of the assigned deliverables and collaborate with internal/ client stakeholders and the client to get the required inputs
- Perform quality review of the safety reports prepared by junior or associate medical writers
- Author or contribute to ad hoc reports, benefit-risk evaluation reports, justification/supporting documents for label updates
Employment Type: Full Time, Permanent
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What Fortrea Development India Private Limited employees are saying about work life
based on 705 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Fortrea Development India Private Limited Benefits
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Fortrea Development India Private Limited Mumbai Office Location
Mumbai Office
Akruti SoftechPark, 2nd Floor, Cross road no 21, MIDC,
Andheri (east), Mumbai
Mumbai
400093
400093
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