http://jobsearch.naukri.com/job-listings-Safety-Associate-I-inVentiv-International-Pharma-Services-Pvt-Ltd-Pune-1-to-2-years-140514005699?xz=1_7_4&xo=&xp=23&xid=140298399793356800&qjt=&qp=&id=&f=-140514005699
| 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 |
| Designation | Safety Associate I |
| 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 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 reconciliations |
| Desired Profile | Bachelors Degree in a life science or nursing; or RN diploma; in Lieu of degree a total of four years relevant experience may be considered. One year relevant experience in Safety/Pharmacovigilance required Good Verbal and written communication skills Good Knowledge of ICH guidelines and regulations relating to Safety Reporting |
| Experience | 1 - 2 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, case processing, safety data reports, Safety associate, Argus, ARISG |
| Contact | yasoda.krishna@inventivhealth.com inVentiv International Pharma Services Pvt Ltd |
| Job Posted | 16 Jun |
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