inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to quality that is unmatched in the industry. For pharmaceutical, Biotechnology, generic drug, and medical device companies of all sizes around the world, inVentiv Health Clinical can help you transform promising ideas into commercial reality. inVentiv Health Clinical can conduct your Phase I – IIa clinical trials, quickly and efficiently in healthy and special populations. Our extensive database ensures rapid study participant recruitment and collaborations with world leading hospitals and research centers.
Job Title : Safety Associate II
Qualification : MSc (Microbiology, Biotechnology)
Job Description :
- Review serious adverse experience (SAE) information received from Investigatorsites and adverse experiences (AEs) from post marketing sources for completeness and regulatory compliance
- Prepare safety data reports for submissions to clients
- Prepare expedited Safety Reports for submission to Regulatory Authorities
- Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings
- Communicate with Clinical Operations and clients to ensure compliance with safety and pharmacovigilance SOPs
- Assist in compilation of regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports
- Assist the safety lead for projects; to include set-up, project management, client liaison
- Perform literature searches
- Assist with SAE reconciliation
Experience : 2-3 years
How to Apply :
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