Safety Associate I | Pune

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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 I | Pune
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
Requirements	•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
City	Pune
Country	India [IN]

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