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.
Vacancy for Bachelors / Master’s degree preferably in pharmacy as Safety Associate II in inVentiv Health
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.
Post: Safety Associate II
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
• Maintain current knowledge of all applicable FDA/EU/ICH guidelines and regulations relating to safety and pharmacovigilance reporting
Candidate Profile:
•Candidate should have 2-3 years of experience in Pharmacovigillance with core case processing experience. ARGUS database experience preferred
•Bachelors / master’s degree preferably in pharmacy, life science, Ayurveda medicine (allied medicine), MSc (Microbiology, biotechnology).
•Local Candidates will be preferred.
•Possess good communication skills
Additional Information:
Experience: 2-3 Years
Location:Pune
Industry Type: Clinical Research
Functional Area: Medical Writing
Last Date: 6th Oct, 2013
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