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