Organization Overview:
inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.Title:
Safety Associate II | PunePosition 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 compliancePrepare 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
Requirements:
Candidate should have 2-3 years of experience in Pharmacovigillance with core case processing experience. ARGUS database experience preferredBachelors / master’s degree preferably in pharmacy, life science, Ayurveda medicine (allied medicine), MSc (Microbiology, biotechnology).
Local Candidates will be preferred.
Possess good communication skills
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