Project Lead, Pharmacovigilance Operations

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

Key Accountabilities:

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 Services. 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 Management and Communication with Sponsor.

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.

Also to 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.
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In addition the SSPL will 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

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.

• 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.

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

• Maintenance of a project plan (Planisware or other tool)

• Monthly revenue recognition and forecast activities

• Invoicing according to contract-service and pass-through cost (in cooperation with Project Analyst)

• Provide project information to Project Analysts

• First point of contact for the client for all financial related issues (e.g. CIS reminders)

• 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 Project Leader (PL) if 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 have the following tasks:

• Clinical trial safety management receipt, processing, data basing, follow-up

• Clinical trial medical monitoring – review of endpoints, lab alerts and waivers

• Clinical trial cumulative and /or per-patient data review

• Post Marketing PV – receipt, processing, data-basing, follow-up and regulatory reporting of spontaneous adverse drug reactions (ADRs), author and review project-specific standard operating procedures related to ICSR management, conduct and review of literature searches, signal management, preparation and submission of PSUR/DSURs

Also, 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 services processes current as required by regulations and SOPs and to document competencies appropriately in the training documentation files.

The SSPL will be single operational point of contact in Medical/Safety Services for this communication.