Safety Services Project Leader

The Safety Services Project Leader (SSPL) will provide leadership, management, general oversight and direction for Medical Services projects, including medical monitoring, clinical and post -marketing pharmacovigilance. You will also be responsible to ensure client satisfaction, project team management and communication, adequate resource planning and allocation, and financial performance related to safety services.

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.

Responsibilities:

· 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.

· 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).

· 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 Business Development 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 performance against plan.Qualifications- Degree in a science related subject combined with industry related work experience in Pharmacovigilance

- 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