Medical Information/Pharmacovigilance Project Manager

Responsibilities

The Project Manager oversees the delivery of Medical Information and Pharmacovigilance services, ensuring compliance with quality standards and regulatory requirements. They act as the primary client contact, managing project financials, operational metrics, and team coordination across the EU.

Requirements

Candidates must hold a university degree in a Life Science field and possess at least 5 years of experience in Pharmacovigilance or Medical Information project management. Strong knowledge of international regulations, safety databases, and excellent communication skills are required.

Skills

• Pharmacovigilance
• Medical information
• Project management
• Quality management system
• Medical inquiry handling
• Safety information intake
• Regulatory compliance
• ICH guidelines
• EU GVP modules
• Client relationship management
• Budgeting
• Forecasting
• Data management
• Communication skills
• Presentation skills
• Drug safety strategy

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
• Team building
• Global meetings

About this role

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
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

About Biomapas

Research Services · 201-500 employees · headquartered in Kaunas · founded 2001