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Job Summary
- Company Name: inVentiv Health Clinical
- Location: Pune
- Experience: 1 - 2 Years
- Keywords / Skills: Drug Safety, Pharmacovigilance, case processing, safety data reports, Safety associate, Argus, ARISG
- Function: Pharmaceutical/ Biotechnology
- Role: Data Management/ Statistics,Drug Safety Officer
- Industry: Bio Technology & Life Sciences,Pharmaceutical
- Posted On: 16th May 2014
About Company
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
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
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
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