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.
Pharmacovigilance Specialist – Case Processing
🔥 0 minutes ago
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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
• Oversee and manage the workflow of safety case reports, ensuring efficient processing • Perform triage on safety case reports to assess priority and necessary actions • Review, manage, and file source documentation in compliance with regulatory requirements • Process safety case reports, including SDB data entry, narrative writing, seriousness assessment, medical review, causality and expectedness assessments, and reporting requirements evaluation • Conduct follow-up activities and manage queries related to safety case reports • Execute quality control checks on data entry and case processing to ensure accuracy and compliance • Reconcile safety case reports to ensure consistency and completeness of data • Prepare line listings to summarize and report on safety case data • Communicate with the Pharmacovigilance Team Leader and Pharmacovigilance Manager regarding operational delivery, quality standards, client relationships, company reputation, and ad hoc project tasks
🎯 Requirements
• University degree in Life Science field • At least 1 year of experience in Safety and Pharmacovigilance within the pharmaceutical or Contract Research Organization (CRO) industry • Proficiency in both verbal and written local language and English • Strong expertise with MS Office • Beneficial experience with Veeva Vault Safety system • Knowledge of EU GVP modules and applicable global safety regulations, including ICH and FDA reporting requirements • CV must be in English language for further assessment
🏖️ Benefits
• Full remote flexible work • Professional growth and career opportunities • International team and environment
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