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Safety Services Project Leader (Ireland)

Parexel International Corporation

Ireland - Any Region - Home Based

The Safety Services Project Leader (SSPL) will provide leadership, management, general oversight and direction for Medical Services projects, including but not limited to medical monitoring, clinical and post -marketing pharmacovigilance. The SSPL will also be responsible to ensure client satisfaction, project team management and communication, quality, adequate resource planning and allocation, and financial performance related to safety services. Depending on the project, the SSPL may serve as a Functional Leader on a full service project or a Project Leader on standalone project. When serving as the functional lead, the SSPL will serve as the primary point of contact and communication between the Parexel Project Leader, the Sponsor team and Medical Services worldwide and, with the Global Lead Physician (GLP) be accountable for performance of the entire Medical Services team on that project. Depending on the project, the SSPL may serve as a Functional Leader on a full service project or a Project Leader on standalone project. When serving as the Functional Leader, the SSPL will provide leadership, management, general oversight and direction for Medical Safety Services projects, including but not limited to medical monitoring, clinical and post -marketing pharmacovigilance. The SSPL will also be responsible to ensure client satisfaction, project team management and communication, quality, adequate resource planning and allocation, and financial performance. The SSPL will serve as the primary point of contact and communication between the Parexel Project Leader, the Sponsor team and Medical Services worldwide and, with the Global Lead Physician (GLP) be accountable for performance of the entire Medical Services team on that project. As a Functional Leader, the SSPL will be responsible for management, general oversight and direction for Safety Services projects, including medical monitoring and clinical and post - marketing Pharmacovigilance (PV) projects. The SSPL will also be responsible to provide input, advice and direction for project resource planning and allocation, and overall Safety Services project team management. The SSPL will also be a point of communication contact and liaison with internal and external stakeholders, strategic planning teams and project review teams including Quality, financial performance and customer feedback. The SSPL will be responsible for consistent and complete communication between all members of the Worldwide Safety team. In addition, in the functional lead role, the SSPL will be responsible to provide input, advice and direction for resource planning and allocation working closely with the global resource planning office, project team management, stakeholder liaison, strategic planning and reviews: · Management, support, direction, coordination and planning for any medical and other pharmacovigilance (PV) related activities, including oversight of and contribution to PV consulting projects. · Strategic input, including providing subject matter expertise for Safety Services in the planning and setup of projects, including costing, budgeting, resourcing, workflow and process design and analysis. · Provide training and mentoring to other, less experienced SSPLs and Safety Operations Staff. · Timely contribution to and strategic input and review of proposals (RFP), and contracts as required. · Liaison with internal (e.g. business operations, account management, Parexel Consulting) and external stakeholders (e.g. clients, third party vendors, health authorities). · Represent Medical/Safety Services if and when required for internal and external matters. · Provide support in internal and external audits and inspections and ensure that corrective actions are implemented as appropriate. · Contribute to Medical and PV Operations resource planning and strategy.QualificationsEssential Skills / Experience Required:-

- Excellent knowledge of drug safety and the drug development process

- Excellent knowledge of and ability to interpret and apply global safety and other relevant regulations

- Experience in evaluation of safety data and the preparation of safety reports

Job posted: 2022-03-05

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