ERGOMED

Manager

• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project
• Develop and maintain a project specific Quality Management Plan
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client's QMS are adhered to by the Project
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects

Client Quality Manager

• Implementation and maintenance of the quality system and training for assigned client projects
• Ensures project maintains compliance with global regulations, legislation, PrimeVigilance and Client requirements
• Oversight of all project related quality activities
• Drive project related quality improvement and providing quality advice
• Client management including direct oversight for client quality related activities for project
• Develop and maintain a project specific Quality Management Plan
• May act as main point of contact for all audit related activities for project and involvement in Deviation and CAPA Management responsibilities
• Ensures relevant quality KPIs are established and monitored
• Provide quality content and analysis for project monthly reports
• Working closely with Quality Management, Quality Assurance and Audit Management teams ensuring all aspects of company and client’s QMS are adhered to by the Project
• Supporting junior members of the team and possible line management responsibilities, involvement in training of employees on client projects

• Prepare year-end current and deferred tax provisions for the Group and related footnote disclosures including liaising with internal finance teams, external advisors and the external auditors.
• Preparation of detailed corporation tax computations for Irish, UK and US entities and liaising with external advisors to finalize and submit corporate tax returns.
• Manage tax instalment/payments on account processes for UK and US Group entities.
• Manage VAT compliance for Head Office companies and review of VAT compliance for UK entities.
• Manage all group reporting with respect to tax transfer pricing matters including working with external advisors to update and refresh tax transfer pricing reports.
• Working with local and centralized finance teams, manage and oversee tax compliance processes across all other jurisdictions where the Group has operations.
• Prepare detailed workings and working with external advisors manage the overall process for the Group’s research and development tax credit claims.
• Manage tax transfer pricing strategies and their implementation including inter-group funding arrangements across the Group.
• Support the Corporate Development Team and external advisors, manage tax aspects of M&A transactions.
• Implement opportunities for tax efficiencies, while maintaining compliance standards and minimizing tax risk.
• Monitor legislative and regulatory changes globally and assess their impact on the Group’s operations.
• Partner with Finance, Legal, HR, Treasury, and Operations across all tax heads.
• Provide tax support and expertise to operational teams including providing advice on tax aspects of sponsor and site contracts.

Tax Manager

Compliance

• Act as Local Contact Person for Pharmacovigilance for the designated country
• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables, driving the team to meet the agreed targets and to comply with the agreed procedures, trackers and templates
• With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
• Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
• Ensure correct training assignment to and training compliance by the LCPs
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Prepare client’s invoices and review/approve vendors’ project invoices
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Stay abreast of changing regulatory legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Track LCPs' key performance indicators and prepare monthly summary reports
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department / company initiatives and contribute to the design/review of SOPs/working practice/guidance.

Senior Specialist, Regulatory & PV Network

• Prepare year-end current and deferred tax provisions for the Group and related footnote disclosures including liaising with internal finance teams, external advisors and the external auditors
• Preparation of detailed corporation tax computations for Irish, UK and US entities and liaising with external advisors to finalise and submit corporate tax returns
• Manage tax instalment/payments on account processes for UK and US Group entities
• Manage VAT compliance for Head Office companies and review of VAT compliance for UK entities
• Manage all group reporting with respect to tax transfer pricing matters including working with external advisors to update and refresh tax transfer pricing reports
• Working with local and centralized finance teams, manage and oversee tax compliance processes across all other jurisdictions where the Group has operations
• Prepare detailed workings and working with external advisors manage the overall process for the Group’s research and development tax credit claims
• Manage tax transfer pricing strategies and their implementation including inter-group funding arrangements across the Group
• Support the Corporate Development Team and external advisors, manage tax aspects of M&A transactions
• Implement opportunities for tax efficiencies, while maintaining compliance standards and minimizing tax risk
• Monitor legislative and regulatory changes globally and assess their impact on the Group’s operations
• Partner with Finance, Legal, HR, Treasury, and Operations across all tax heads
• Provide tax support and expertise to operational teams including providing advice on tax aspects of sponsor and site contracts

• Resolves assignments from Board, President, SDMD Head and Director of ICSR
• Line Manages assigned Team Leads and supports their teams
• Ensures effective Line Management in assigned teams (up to 15 direct reports/line manager spread globally)
• Reviews project resourcing and ensures proactive assignment to avoid/minimize backlogs
• Supports Business Development and Proposals with any existing and new opportunities
• Supports Team leads with deviation management
• Reviews and approves all minor and major CAPAs from the ICSR Management Unit
• Supports other departments, as agreed with Director of ICSR
• Works independently, with support from Director of ICSR
• Supporting the RA & PV Network Department as needed, including acting as the LCPPV (Local Contact Person for Pharmacovigilance) for the specified country and taking on the role of PRLS (Person Responsible for Local Screening) for the designated language, as agreed with the line manager

Senior ICSR Operational Lead – Pharmacovigilance

Senior Pharmacovigilance Line Manager – ICSR Operational Lead

Research Analyst

• Performs on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visit activities
• Identifies the investigators and verifies that the investigator has adequate qualifications, resources, facilities, equipment and staff
• Trains investigational site staff as necessary
• Supports preparation of regulatory and / or EC submissions
• Participates in mentoring/training of new staff as well as performing co-monitoring visits

Clinical Research Associate II

Human Resources

• Act as a strategic partner to global business leaders
• Collaborate with regional/local HR teams and CoE
• Serve as a trusted advisor and thought partner to senior leadership
• Participate in development and execution of global workforce planning initiatives
• Support the design and implementation of global performance management processes and tools
• Oversee global retention and development strategies
• Understand and keep a “pulse” on overall staff engagement
• Lead HR initiatives related to organizational change, mergers, acquisitions, and restructuring
• Support the design and implementation of global compensation and benefit processes

Global Human Resources Business Partner

Project Manager

• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget, and are on time with good quality and in compliance with the applicable regulatory requirements.
• Providing support to Director of Projects and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company.
• Acting as the primary contact point for project-related matters.
• Workflow management, KPI/metric reporting.
• Manage changes to the project scope, project schedule and project costs, as applicable.
• Maintaining good client relations and ensuring a consistently high quality of work for each client.
• Understand client PV requirements and ensure service provided addresses all requirements.
• Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings.
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones.
• Assurance of training of all team members from relevant quality documents, including project-specific documentation.
• Close cooperation with other Primevigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines.
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope.
• Preparation of client specific core documents (e.g. Join operational guidelines, Safety management plan, Monthly reports, etc), as applicable.
• Preparation of invoices, project financial analysis.
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance.
• Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines, maintaining compliance with the PV system and providing PV training, as required.

Principal/Senior Pharmacovigilance Project Manager

• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget, and are on time with good quality and in compliance with the applicable regulatory requirements.
• Providing support to Director of Projects and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company.
• Acting as the primary contact point for project-related matters
• Workflow management, KPI/metric reporting
• Manage changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Understand client PV requirements and ensure service provided addresses all requirements
• Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones
• Assurance of training of all team members from relevant quality documents, including project-specific documentation
• Close cooperation with other Primevigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Preparation of client specific core documents (e.g. Joint operational guidelines, Safety management plan, Monthly reports, etc), as applicable
• Preparation of invoices, project financial analysis
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines, maintaining compliance with the PV system and providing PV training, as required

• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget, and are on time with good quality and in compliance with the applicable regulatory requirements.
• Providing support to Director of Projects and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company.
• Acting as the primary contact point for project-related matters
• Workflow management, KPI/metric reporting
• Manage changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Understand client PV requirements and ensure service provided addresses all requirements
• Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones
• Assurance of training of all team members from relevant quality documents, including project-specific documentation
• Close cooperation with other Primevigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Preparation of client specific core documents (e.g. Join operational guidelines, Safety management plan, Monthly reports, etc), as applicable
• Preparation of invoices, project financial analysis
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines, maintaining compliance with the PV system and providing PV training, as required

• Ensuring that all contracted activities performed on behalf of PrimeVigilance clients are delivered within budget, and are on time with good quality and in compliance with the applicable regulatory requirements
• Providing support to Director of Projects and senior leadership management, as applicable, in other activities undertaken on behalf of the client and the company
• Acting as the primary contact point for project-related matters
• Workflow management, KPI/metric reporting
• Manage changes to the project scope, project schedule and project costs, as applicable
• Maintaining good client relations and ensuring a consistently high quality of work for each client
• Understand client PV requirements and ensure service provided addresses all requirements
• Project set-up and maintenance activities planning; Organising/chairing and attending regular client meetings
• Having an overview of all tasks to be delivered to the client, including deadlines and interim milestones
• Assurance of training of all team members from relevant quality documents, including project-specific documentation
• Close cooperation with other Primevigilance and/or the client’s respective departments making sure contracted activities are delivered with high quality and within set timelines
• Assurance that all Primevigilance departments and respective personnel are familiar with the client and the project scope
• Preparation of client specific core documents (e.g. Join operational guidelines, Safety management plan, Monthly reports, etc), as applicable
• Preparation of invoices, project financial analysis
• Advising the client as requested or as appropriate in PV matters such as changes in regulations/guidance
• Managing Quality Management System activities for the client; development of standard operating procedures and operational guidelines, maintaining compliance with the PV system and providing PV training, as required

Medical writer

• Independent authoring, editing and reviewing of various regulatory/clinical documents (e.g. aggregate reports, risk management plans and other documents needed throughout the product’s life cycle) with the responsibility for the quality and content of the document and compliance with internal and external standards
• Active participation in trainings and development, implementation and maintenance of quality system documents for medical writing, including internal templates and formats required for standardised documentation
• Support in all pharmacovigilance operations associated with medical writing
• Continuous self-education in all aspects associated with medical writing
• Managing a team of junior medical writers

Client Quality Manager

Client Quality Manager

Tax Manager

Senior Specialist, Regulatory & PV Network

Tax Manager

Senior ICSR Operational Lead – Pharmacovigilance

Senior Pharmacovigilance Line Manager – ICSR Operational Lead

Clinical Research Associate II

Global Human Resources Business Partner

Principal/Senior Pharmacovigilance Project Manager

Principal/Senior Pharmacovigilance Project Manager

Principal/Senior Pharmacovigilance Project Manager

Principal/Senior Pharmacovigilance Project Manager

Principal/Senior Pharmacovigilance Project Manager

Medical Writer III – Line Management Experience Required