Safety Associate I @ inVentiv Health "P"

Job Description:
Position Overview
This role is majorly involved in case processing, and possibly quality review.

Responsibilities
• 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 reconciliation

Candidate Profile:
•Candidate should have 1-2 years of experience in Pharmacovigillance
•Candidate must have experience in case reporting.
•Candidate with regulatory experience will be preferred
•Candidate with experience in ARISg/ARGUS database will be preferred
•Possess good communication skills

Additional Information:
Experience: 2-3 Years
Location: Pune
Last Date: 30^th April, 2014

CLICK HERE TO APPLY