Pharmacovigilance Project Manager

🔥 10 minutes ago

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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

• To oversee and manage strategic/key accounts • Maintain high quality regular communication with Clients contact persons • Ensure high quality performance of activities in scope through effective liaising with Biomapas staff responsible for PV regional management • Effectively manage a team supporting project management activities • Manage and track assigned projects invoices • Oversee project financials and profitability • Support in developing project management process • Support in preparations and attendance of bid defences • Involve in forecasting and project budgeting • Support team with issue resolution and workflow distribution

🎯 Requirements

• Life science degree • 5-year experience in Pharmacovigilance, including case processing • Experience with end-to-end case processing of clinical trials • Oncology background preferred • Veeva Vault handling mandatory • Fluent English • Excellent knowledge of international regulations (ICH, EU GVP Modules) • Strong computer literacy with intensive experience with safety data bases and MS Office • Demonstrated ability to set up and implement drug safety strategies, develop PV 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 • Rewarding business referral policy • Employee referral policy • Flexible working hours, remote working