The Medical Information/Pharmacovigilance Project Manager oversees service delivery, coordinates project activities, manages financials, and maintains client relationships within the Pharmacovigilance and Medical Information department. Responsibilities include ensuring compliance with quality management systems, monitoring operational metrics and service-level agreements, supporting database implementations, and acting as the primary contact for clients. Candidates require a life science university degree and at least five years of project management experience in pharmacovigilance or medi…
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
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