Manager, Pharmacovigilance

Manager, Pharmacovigilance- Systems

ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

Job Description Summary

This role is for an STL (Safety Technology Lead) within the PVSS / SRG group.

• The primary function is to serve as a global contact and interface for the PV business for ICON Safety Systems.
• Provides expertise, training and project management support to the Argus and Safety Reporting System (SRS) user community (internal external) in gathering and documenting user requirements, database set-up, testing, maintenance and database migrations.
• Work closely with vendors to provide full system support capabilities.
• Keep management appraised of any potential/actual study or staffing issues and assist with developing solutions
• Assist with maintenance of project budgets and oversight by identifying out of scope activities
• Serve as a mentor and role model for Systems staff
• Assist upper management with resourcing and business development activities
• Manage PV projects including Sponsor liaison, and management of timelines and budgets as appropriate
• Ensure audit readiness and PV Systems representation at audits
• Other activities as identified and requested by management
• Successful completion of ICON safety database related projects on-time, within budget limits and with approved quality levels to support achievement of the department s overall financial and quality goals and objectives.
• Ensure all assigned project and departmental activities are completed in accordance with ICON standards, regulatory requirements, and contractual obligations to Sponsors

Job Description - Key Highlights

• The employee is expected to demonstrate the ICON leadership competencies.
• Gather and document user requirements specific to ongoing PV systems projects.
• Guides User Acceptance Testing and assumes the role of the SME on behalf of the Safety Team.
• Provides systems expertise (Argus SRS) to end users for issue resolutions.
• Identifies where controlled documentation is required and ensures it is put in place e.g. supporting database set up, updates, changes and data migrations.
• Develops procedures for documenting process development as it relates to the ICON safety database.
• Reviews and collaborates with users to perform impact assessments for requested changes.
• Working closely with the IT team who support Safety Systems on changes impacting users.
• Facilitates the accurate configuration of Argus databases through working with users and the Safety Systems Team to ensure that requirements are documented correctly.
• Work with colleagues, management, and other departments as necessary, to implement change / process and systems improvement.
• Complete all departmental project activities accurately and in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes.
• Serve as the main point of contact for the customer for the life-cycle of assigned systems projects.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. Were proud of our diverse workforce and the work we ve done to become a more inclusive organisation. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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