Job Description

Join our global Pharmacovigilance and Medical Information department as a Medical Information/Pharmacovigilance Project Manager.

Medical Information/Pharmacovigilance Project Manager ensures compliance with the Quality Management System, coordinates project activities, oversees project financials, and fosters long-term client relationships.

Position applicable only for EU countries. All CV's must be submitted in English language for assessment.

Responsibilities

• Oversee Medical Information and Pharmacovigilance service delivery, including medical inquiry handling and response management, safety information intake and reporting, quality oversight, and compliance with applicable procedures and timelines
• Act as the primary contact point for project-related matters for the client and internally, and manage client accounts
• Ensure high quality performance of activities in countries in scope through effective liaising with Biomapas staff responsible for PV/MI regional management
• Coordinate and support the implementation, maintenance, and optimization of Medical Information databases and inquiry management systems
• Ensure appropriate oversight of operational metrics, reporting, and service-level agreements (SLAs)Oversee PV/MI projects’ financials and profitability, forecasting and project budgeting
• Support in developing project management process
• Support in preparations and attendance of bid defenses

Requirements

• University degree in the Life Science field
• At least 5-year experience in Pharmacovigilance and/or Medical Information Project Management experience from ideally a service provide / CRO
• Strong knowledge of Medical Information processes, including medical inquiry handling, scientific response management, documentation, and quality requirements.
• Hands-on experience with Medical Information databases, inquiry management systems, or related MI technology platforms is highly preferred.
• Fluent English
• Excellent knowledge of international regulations (ICH, EU GVP Modules)
• Excellent client-facing skills including strong communication and presentation skills
• Strong computer literacy with intensive experience with safety databases and MS Office
• Demonstrated ability to set up and implement drug safety strategies, develop PV/MI related procedures, elevate and resolve issues
• Strong communication, organizational and time management skills
• Ability to work independently and in a team

Benefits

• Professional growth and career opportunities
• International team and environment
• Personal accident and business trip insurance
• Additional health insurance
• Remote/home based
• Rewarding referral policy
• Workplace establishment allowance (fully remote)
• Team building, global meetings