Medical Information/Pharmacovigilance Project Manager

Job not on LinkedIn

🔥 4 minutes ago

🌐 Bulgaria, Croatia, +3 more countries – Remote

🇧🇬 Bulgaria – Remote 🇭🇷 Croatia – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote 🇬🇷 Greece – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 10%

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• Jobs at this company usually fill in 32 days.
• No salary listed.

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Biomapas is a comprehensive outsourcing solution provider catering to the global life science sector. The company acts as a strategic partner for biopharmaceutical and medical device companies, offering extensive clinical research services worldwide. Biomapas covers the entire product lifecycle from regulatory compliance to pharmacovigilance and medical information. The company operates across various regions including Europe, CIS, EAEU, MENA, LATAM, and the US, ensuring high-quality, efficient, and cost-effective methodologies to deliver superior service and strategic advantages. With a focus on clinical trials, pharmacovigilance, and regulatory affairs, Biomapas is equipped to navigate complex regulatory environments and manage clinical trial data effectively, contributing to clients' commercial success.

📋 Description

• 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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