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.
Local PV Support Person, Medical Information Specialist - Freelance
Job not on LinkedIn
🔥 0 minutes ago
🗣️🇮🇸 Icelandic Required
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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
• Perform local PV operations and ensure compliance with safety regulations and procedures • Manage ICSRs and FUs • Review local literature • Review local legislation • Perform PV trainings to MAH employees • Handle Medical Information Requests • Support Biomapas Clients with other PV related tasks • Manage daily operations, ensure compliance, exchange safety information, and serve as a contact for timely safety processing • Collaborate closely with Nordic local safety officers and medical information specialists
🎯 Requirements
• Degree in Medicine, Biomedicine, Pharmacy, or Nurse • Fluent in written and spoken English and native Icelandic • Preferably at least 2 years experience in pharmacovigilance • In-depth, demonstrated experience in most areas pertaining to pharmacovigilance and pharmacovigilance legislation • Excellent knowledge of local and international regulations (ICH, EU GVP Modules) • Analytical skills to understand, analyze, interpret, and present scientific data • Ability to interpret and apply global and local drug safety regulations • High motivation to develop and learn within the team • Submit your CV in the English language
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