This is to keep you informed that, Quintiles is hiring for “Pharmacovigilance” (Case processing/Aggregate reporting) 1 to 6 years of Relevant experienced candidates for Bangalore location. Please find below JD, if you are interested in exploring career Opportunity please Walk-in on 1st October 2016 from 08.15 AM On-wards @ Quintiles Office in Ahmedabad for interview
Venue Details
Quintiles
B-101-106, Shapath IV
Opp. Karnavati Club
Sarkhej-Gandhinagar Road
Ahmedabad 380 051
Click on below image for zoom view
Purpose
Review, assess and process Lifecycle Safety data and information, across all service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
Responsibilities
· Receive, review and process data from various sources on time and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines
· Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.
· Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
· Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
· Ensure compliance to Quintiles high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables.
Required Knowledge, Skills and Abilities
· Working knowledge of Lifecycle Safety services.
· Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
· Effective written and verbal communication skills.
Minimum Required Education and Experience
· 1+ years’ relevant experience in Pharmacovigilance is mandate.
Job location is Bengaluru and will involve 2 shifts either (6 AM -2:30 PM or 2 PM -10:30 PM) the shifts will be decided by the Hiring Manager
Kind Regards,
Shanmuga Sundaram
Mobile: 99003 55522
Office: 08071311051
Shanmuga.Sundaram@quintiles.com
Venue Details
Quintiles
B-101-106, Shapath IV
Opp. Karnavati Club
Sarkhej-Gandhinagar Road
Ahmedabad 380 051
Click on below image for zoom view
Purpose
Review, assess and process Lifecycle Safety data and information, across all service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
Responsibilities
· Receive, review and process data from various sources on time and meet quality standards. Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, driving case closure, coordinating translations and ensuring reports are sent to the customer within assigned deadlines
· Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards and investigators, oversight groups per legislation, within timelines and in a format compatible to requirement.
· Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
· Liaise with different functional team members, e.g. project management, clinical, data management; health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
· Ensure compliance to Quintiles high quality standards and work with LSM constructively in a matrix framework to achieve project and customer deliverables.
Required Knowledge, Skills and Abilities
· Working knowledge of Lifecycle Safety services.
· Basic knowledge of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, SOPs.
· Effective written and verbal communication skills.
Minimum Required Education and Experience
· 1+ years’ relevant experience in Pharmacovigilance is mandate.
Job location is Bengaluru and will involve 2 shifts either (6 AM -2:30 PM or 2 PM -10:30 PM) the shifts will be decided by the Hiring Manager
Kind Regards,
Shanmuga Sundaram
Mobile: 99003 55522
Office: 08071311051
Shanmuga.Sundaram@quintiles.com
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