Medical It Specialist Job in Parexel International Corporation
Medical It Specialist
Parexel International Corporation
4+ weeks ago
- Hyderabad, Telangana
- Not Disclosed
- Full-time
- Permanent
Job Summary
Set-up and support activities associated with the Parexel Safety database including but not limited to:
New study set-up
Periodic report configuration and generation
Ad-hoc report configuration and generation
Expedited report rule configuration
End-user support
Set-up and support activities associated with the Safety
Information System (S IS) including but not limited to:
New study, site, and user set-up
Report distribution rule configuration
End-user support
Work closely with Parexel IT, vendor, and/or Parexel Safety Services staff proper analysis, resolution and closure of issues for supported systems
Support the handover of the safety database from client to Parexel where contracted to take over the pharmacovigilance tasks for client projects.
Support the handover of safety data from Parexel to client at the end of study/project as contracted
Act as a point of contact both internally and with external clients to develop programs and processes to meet requirements of both clients and regulatory agencies
Provide technology support to Safety Services for the purposes of business process optimization and improvement
Support software updates, change requests and application support for the supported applications
Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards
University/College degree in Life Science with strong technology background.
Skills:
Excellent interpersonal, verbal and written communication skills
Client focused approach to work
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix environment and to value the importance of teamwork
Excellent problem-solving skills.
Strong understanding of E2B and Regulatory processes
Knowledge and Experience:
Experience in the maintenance and support of databases that support a worldwide distributed user base within a regulated industry environment
Specific experience in one or more of the following areas: ARGUS Safety, ArisG, ORACLE SQL or PL/SQL, VB and any other I.T. discipline that would be of value for safety databases
Understanding of the Clinical Research and development process including post-marketing approval, in particular with respect to patient safety and regulatory reporting requirements.
New study set-up
Periodic report configuration and generation
Ad-hoc report configuration and generation
Expedited report rule configuration
End-user support
Set-up and support activities associated with the Safety
Information System (S IS) including but not limited to:
New study, site, and user set-up
Report distribution rule configuration
End-user support
Work closely with Parexel IT, vendor, and/or Parexel Safety Services staff proper analysis, resolution and closure of issues for supported systems
Support the handover of the safety database from client to Parexel where contracted to take over the pharmacovigilance tasks for client projects.
Support the handover of safety data from Parexel to client at the end of study/project as contracted
Act as a point of contact both internally and with external clients to develop programs and processes to meet requirements of both clients and regulatory agencies
Provide technology support to Safety Services for the purposes of business process optimization and improvement
Support software updates, change requests and application support for the supported applications
Ensure adherence to regulations concerning computer system validation, 21 CFR Part 11 compliance, procedures, and quality standards
Qualifications
Education:University/College degree in Life Science with strong technology background.
Skills:
Excellent interpersonal, verbal and written communication skills
Client focused approach to work
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix environment and to value the importance of teamwork
Excellent problem-solving skills.
Strong understanding of E2B and Regulatory processes
Knowledge and Experience:
Experience in the maintenance and support of databases that support a worldwide distributed user base within a regulated industry environment
Specific experience in one or more of the following areas: ARGUS Safety, ArisG, ORACLE SQL or PL/SQL, VB and any other I.T. discipline that would be of value for safety databases
Understanding of the Clinical Research and development process including post-marketing approval, in particular with respect to patient safety and regulatory reporting requirements.
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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