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Biomapas

Medical Information/Pharmacovigilance Project Manager

Biomapas Croatia

Research Services · 201-500 employees

6 h ago
Remote project-manager Senior (5-10 yrs) Full-time Croatia
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About the role

The Project Manager will oversee Medical Information and Pharmacovigilance service delivery, ensuring compliance with quality standards and regulatory requirements. They will also manage client accounts, project financials, and coordinate the implementation of inquiry management systems.

What they look for

Pharmacovigilance Medical information Project management Quality management system Budgeting Forecasting Client relationship management Safety database management Regulatory compliance ICH guidelines EU GVP modules Scientific response management Data analysis Communication Presentation skills Organizational skills

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 and proficiency in safety databases are essential for this role.

Benefits

Personal accident insurance Business trip insurance Additional health insurance Rewarding referral policy Workplace establishment allowance Team building Professional growth opportunities

Full 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
  • 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

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