Senior Pharmacovigilance Specialist

🔥 16 hours ago

🌐 Croatia, Bulgaria, +4 more countries – Remote

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⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Logo of Biomapas

Biomapas

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

• Support global and local PV systems and ensure compliance with international or local regulations • Take on additional regional or local PV responsible person roles for simple PV systems • Act as Project Manager or deputy Project Manager for assigned projects • Perform accurate forecasting and contribute to budget planning for efficient functioning of the QPPV Office • Update SOPs and act as a subject matter expert for PV in assigned company processes • Maintain KPI reports and perform core and standard PV activities for assigned contractual partners • Manage full or local Pharmacovigilance systems and projects, central pharmacovigilance activities, end-to-end case processing, Aggregate Safety Reports, Risk Management Plans, and risk minimization activities • Act as customer contact point, ensuring consistent communication and escalation management across assigned projects • Act as appointed EU QPPV or deputy EU QPPV, if applicable • Ensure high-quality PV service performance in the assigned region/country and timely communication with Health Authorities • Ensure inspection/audit readiness and finding remediation

🎯 Requirements

• Biologist, Pharmacist, Medical Doctor, or other life science degree • 4-year experience in global Pharmacovigilance activities • Fluent English • Computer literacy (MS Office), experience with PV databases (Veeva Vault Safety experience is an advantage) • Strong organizational and time management skills • Ability to work independently and in a team • Strong organization, prioritization, and time management with reliable delivery of commitments • Strong communication and relationship building skills across functional teams

🏖️ Benefits

• Professional growth and career opportunities • International team and environment • Bonus based on annual performance • Personal accident and business trip insurance • Additional health insurance • Remote/home based • Rewarding referral policy • Workplace establishment allowance (fully remote) • Team building, global meetings, B active events

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