The Safety Services Project Leader (SSSPL) 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.
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.
Contribute to the costing of Medical and PV Operations projects, including the review of and improvement of performance metrics and costing tools.
Attend and lead client meetings and bid-defense meetings.
When serving as the Project Leader on standalone projects, the SSPL is independently responsible for all Project Leader tasks and deliverables according to SOPs on assigned projects including :
Attend and lead Bid Defense Meetings along with the BD team.
Develop and maintain a formal project plan with all key milestones, budgets, and resources assigned to specific tasks and outcomes.
Define metrics for reporting against plan.
Ensure that all standard project systems and tools are set up correctly and functioning appropriately.
Implement operational strategy as defined in the project plan and makes changes to the plan to ensure desired results. · · · Proactively solve problems in collaboration with the client and project team.
Close out of all project activities upon project completion; perform financial reconciliation and system closeout.
Excellent knowledge of drug safety, drug development, and ability to interpret / apply global safety regulations.
Experience in evaluation of safety data and the preparation of safety reports.
Experience with computer applications including database management and pharmacovigilance related systems.
Ability to :
Previous post-marketing experience highly preferred.
Customer focus, commitment to quality management and problem solving.
Effective communication and negotiation skills.
Budget management skills.
Basic understanding of all aspects of project life-cycle.
Proven track record of developing client relationships.
Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification.