Pharmacovigilance Specialist at Fortrea

England, Londonderry - Northern Ireland, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

03 Jan, 27

Salary

45000.0

Posted On

05 Oct, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Serve as the technical leader on all data management aspects for project(s) including start-up, maintenance, and completion activities.
Develop global Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data.
Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
Serve as the project and client liaison including management and provision of project specific data management status, cycle time, and productivity metrics.
Coordinate and participate in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications.
Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions.
Coordinate the development and testing of data management systems edit / data validation checks) diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
Advanced planning and risk management for projects (issue escalation, resource management).
Oversee the technical performance of the data review project staff on achieving client satisfaction through delivery of quality data, on-time and on-budget.
Assist with goal creation and performance review assessment for data review project staff.
Maintain technical data management competencies via participation in internal and external training seminars.
Ensure project staff are trained and adhere to project-specific, global, standardized data management processes.
Identify areas for process and efficiency improvement and implement solutions on assigned projects.
Support achievement of project revenue and operating margin for data management activities to agreed targets.
Support business development for data management time and cost estimates and prepare and present to potential clients on global data management capabilities.

Responsibilities