Drug Safety Associate
by Quintiles in Bengaluru/Bangalore
Experience: 1 to 6 yrs. | Opening(s): 20
RESPONSIBILITIES
Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, 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. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of secondary review.
Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.
Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
Mentoring less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
May provide oversight role to impart technical and process information to the LSM point of contact and members of operational team.
May provide an oversight role to perform operational and collaborative LSM tasks as directed by Lifecycle Safety Infrastructure.
Participate in team meetings and provide regular feedback to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.
Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
Work with LSM constructively in a matrix framework to achieve project and customer deliverables.
Participate in training across Lifecycle Safety service offerings. Provide project-specific operational process training to junior team members, monitors and investigative site personnel, as appropriate.
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 operational project issues.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
Perform other duties as assigned
APPLY
Receive, triage, review and process Lifecycle Safety data from various sources on time, within budget and quality standards. Perform data entry for tracking and Lifecycle Safety databases, 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. Pre-process material for endpoint committee or core laboratory adjudication. Preparation of material for submission of secondary review.
Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to requirement. Liaise with local Quintiles offices to facilitate expedited reporting. Liaise with systems manager for regulatory tracking requirements and electronic reporting.
Contribute to individual deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting Lifecycle Safety data.
Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.
Mentoring less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow.
May provide oversight role to impart technical and process information to the LSM point of contact and members of operational team.
May provide an oversight role to perform operational and collaborative LSM tasks as directed by Lifecycle Safety Infrastructure.
Participate in team meetings and provide regular feedback to operations team manager and lifecycle safety management (LSM) on operational project metrics, out of scope work challenges/issues and successes.
Ensure compliance to Quintiles high quality standards and works with LSM constructively in a matrix framework to achieve project and customer deliverables.
Work with LSM constructively in a matrix framework to achieve project and customer deliverables.
Participate in training across Lifecycle Safety service offerings. Provide project-specific operational process training to junior team members, monitors and investigative site personnel, as appropriate.
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 operational project issues.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read and acknowledge all necessary Quintiles standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring your individual training plan and training transcript are reconcilable.
Perform other duties as assigned
APPLY
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