Safety Associate II @ inVentive Health Clinical

 

 Job Description :

Review serious adverse experience (SAE) information received from Investigator sites 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 reconciliations
Maintain current knowledge of all applicable FDA/ICH guidelines and regulations relating to safety and Pharmacovigilance reporting

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