Safety Services Project Leader

Great home-based opportunity to join Parexel's best in class Global Medical Sciences Team as a Safety Services Project Leader (SSPL)/(Drug Safety Project Manager)! This highly visible role combines your drug safety, post-marketing, and product launch experience with your project management expertise.

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.
• Contribute to the costing of Medical and PV Operations projects, including the review of and improvement of performance metrics and costing tools. Qualifications ·Attend and lead client meetings, and bid-defense meetings.
• Provide timely input and feedback to process improvement.

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.

In this capacity the SSPL will be responsible for the financial management /administration of the function-led projects according to Corporate Business Operating Procedures to include:

• Maintenance of a project plan
• Monthly revenue recognition and forecast activities
• Invoicing according to contract -service and pass through cost
• Monthly control/adjustment of time reported
• Project close out activities WW (in cooperation with Project Analyst)
• Provide project information to Project Analysts
• First point of contact for the client for all financial related issues
• Coordination/management of project team

In activities involving project management, the SSPL will be acting as the Medical functional lead working with the overall Parexel PL or as the PL if a the project is a function-led Medical project, to ensure that projects run on time, on budget, and in accordance with client contract, SOPs, quality standards and regulatory guidelines.

Projects may involve the following tasks:

• Clinical trial safety management
• Clinical trial medical monitoring
• Clinical trial cumulative and/or per-patient data review
• Post-marketing PV
• Any other activities as required by lifecycle drug safety services.

The SSPL will be required to maintain PV knowledge and knowledge of any other Medical service processes current as required by regulations and SOPs, and to document competencies appropriately in the training documentation files.
The SSPL will be the single operational point of contact in Medical/Safety Services for this communication.

To ensure success, qualified candidates should have the following qualifications:

• Excellent knowledge of drug safety, drug development, and ability to interpret/apply global safety regulations
• Previous post-marketing and/or product launch experience
• Experience in evaluation of safety data and the preparation of safety reports
• Experience w/ computer applications including database management and pharmacovigilance related systems
• Ability to:

build effective project teams, motivate, delegate, and drive timely/quality decision-making
gain trust and confidence with a variety of clients and w/in Parexel
create a sense of urgency and take a proactive, solutions-based approach
prioritize and manage multiple, varied tasks with enthusiasm and attention to detail
thrive in a matrix environment and to value the importance of teamwork
work independently with oversight guidance

• 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 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.