Pharmacovigilance Project Lead

• Is the Single Point of Contact (SPOC) for the contracted Pharmacovigilance activities and assists Project Manager for project operation oversight.
• Provide oversight and direction of all Pharmacovigilance services/ activities throughout the duration of a project (including deliverables and finances) as a Pharmacovigilance subject matter expert.
• Primary liaison for client and project team for Pharmacovigilance services/activities (time, scope, cost, quality, resource) matters with oversight from the Project Manager.
• Liaise with Project Manager, and other cross functional project resources, as appropriate.
• Work with Project Manager to ensure accurate projections of units/hours (revenue and resources) and actual units/hours for all Pharmacovigilance services.
• Assesses upcoming workload and coordinates with the Project Manager and Resource Managers for planning.
• Provides monthly worked units for safety services and performs timely reconciliations to ensure correct life-to-date billing.
• Actively identify and maintains out of scope log for Pharmacovigilance Services to resolution/report to Project Manager.
• Represents Pharmacovigilance and related service updates on client and project team meetings / teleconferences.
• Conducts regular team briefing meeting to ensure team understanding for the project requirements, key decisions and important updates.
• Actively communicates with the client and represents Pharmacovigilance operations in teleconferences with the relevant stakeholders for the assigned projects.
• Responsible to support Pharmacovigilance Project set-up.
• Ensure up to date team training throughout lifecycle of the project.
• Responsible to provide Pharmacovigilance Service input into the Project Management Plan throughout the lifecycle of the project. When assigned to a portfolio, ensures consistency of the PMP and safety documentation across all projects.
• Oversee the development of project specific plans (i.e. Safety Management Plan)
• Ensures delivery of high-quality Pharmacovigilance work by the project team with compliance to the agreed timelines.
• Ensures adherence to company document filing standards and performs regular project file reviews to confirm inspection readiness.
• Proactively identifies, resolves/mitigates through ongoing review of project progress and metrics and escalates risks and/or issues until resolution.
• Conducts safety presentations for bid defense, start-up meetings, Investigator Meetings and other meetings as needed.
• Provide guidance for any audit/inspection activities.
• Monitor quality and compliance for safety deliverables and provides data metrics for inclusion in monthly project reports. Additionally assist management, as required with weekly and monthly project status reports.
• Lead the coordination of any safety or medical information related activities.
• Train/mentor newly hired Pharmacovigilance staff, on project specific task as requested.
• Perform other activities as identified and requested by Pharmacovigilance management.

You should have:

• Overall 6-10 years experience (i.e. major experience in case processing & 1-2 years in PV Project management)
• Qualification: Min. Bachelor's Degree in any Life Science stream
• Should have Global Client facing exposure
• Should be capable of drafting Safety Management Plan & Safety Management Procedure
• Should have understanding of Financial aspects of the project (i.e. Budgeting, Forecasting, Profit Margin, Revenue generation etc.)
• Should have experience in Resource Management