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
- 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
- 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