Senior Safety Associate, 4 - 6 years exp, Pune

Please enter your email ID to get job alerts Thank you for your feedback. This will help us improve the quality of jobs that are available on naukri.com for you. 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. Designation Senior Safety Associate 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 Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements Prepare safety data reports for submissions to clients Prepare and/or review expedited Safety Reports for submission to Regulatory Authorities Communicate with Clinical Operations and clients to ensure compliance with safety and Pharmacovigilance SOPs Prepare regulatory submissions, i.e., Annual Reports, Periodic Safety Update Reports Be the safety lead for projects; to include set-up, project management, client liaison Prepare SAE reporting plans Mentor Safety Associates and other members to the Global Safety and Pharmacovigilance group involved in safety data processing Be responsible for SAE reconciliation for a study Maintain current knowledge of all applicable FDA/ICH guidelines and regulations relating to safety and Pharmacovigilance reporting Desired Profile Bachelors Degree in a life science or nursing; or RN diploma Four years relevant experience in Safety/Pharmacovigilance required which may include up to 2 years of data management, CRA, clinical practice (RN, RPN). Health authority of study coordinator experience Good Verbal and written communication skills Excellent Knowledge of ICH guidelines and regulation relating to Pharmacovigilance Experience 4 - 6 Years Industry Type Pharma / Biotech / Clinical Research Role Other Functional Area Other Education UG - Any Graduate - Any Specialization, Graduation Not Required PG - Any Postgraduate - Any Specialization, Post Graduation Not Required DOCTORATE - Any Doctorate - Any Specialization, Doctorate Not Required Location Pune Keywords Drug Safety, Pharmacovigilance, ARGUS, ARISG, Safety reports, Case Processing Contact Venkata Pradeep inVentiv International Pharma Services Pvt Ltd Job Posted 15 May

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