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Biomapas

Full lifecycle clinical research outsourcing solutions

Medical Information/Pharmacovigilance Project Manager

Clinical Research OperationsPosted on Nov 13
Full-timeRemote in BulgariaNo salary listed

About the Job

Requirements

  • A university degree in a life science field is required.
  • At least five years of experience in Pharmacovigilance and/or Medical Information Project Management, ideally with a service provider or contract research organization.
  • 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 Medical Information technology platforms is highly preferred.
  • Fluent English is required.
  • Excellent knowledge of international regulations, including ICH and EU GVP Modules, is required.
  • Client-facing skills, including communication and presentation skills, are required.
  • Computer literacy with intensive experience using safety databases and Microsoft Office is required.
  • Ability to set up and implement drug safety strategies, develop PV/MI-related procedures, and elevate and resolve issues is required.
  • Strong communication, organizational, and time management skills are required.
  • Ability to work independently and in a team is required.
  • All CVs must be submitted in English 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 by liaising effectively with Biomapas staff responsible for Pharmacovigilance and Medical Information regional management.
  • Coordinate and support the implementation, maintenance, and optimization of Medical Information databases and inquiry management systems.
  • Oversee operational metrics, reporting, and service-level agreements.
  • Oversee Pharmacovigilance and Medical Information project financials and profitability, including forecasting and project budgeting.
  • Support the development of project management processes.
  • Support preparation for and attendance at bid defenses.

Desired Qualifications

  • Hands-on experience with Medical Information databases, inquiry management systems, or related Medical Information technology platforms is highly preferred.
  • Experience in Pharmacovigilance and/or Medical Information Project Management with a service provider or contract research organization is ideally preferred.

About the Company

Biomapas

Full lifecycle clinical research outsourcing solutions

Biomapas provides full outsourcing for life sciences, spanning biopharma, medical devices, cosmetics, and food supplements. It handles clinical research, regulatory submissions, and pharmacovigilance across Europe, CIS, MENA, and LATAM throughout the product lifecycle. It differentiates itself by acting as an in-house, dedicated partner with tailored, end-to-end solutions and strong regulatory and pharmacovigilance expertise. Its goal is to help clients bring products to market efficiently and within budget by integrating as part of the client team from development to commercialization.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
Kaunas, Lithuania
Founded
2001

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