Pharmacovigilance Associate

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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

• Perform routine and foundational pharmacovigilance activities for assigned projects, including case intake, data entry, coding, literature monitoring, and distribution of safety information • Perform initial case intake and triage according to SOPs • Enter and code cases in safety databases with supervision • Assist with follow-up requests, tracking, and documentation • Prepare cases for quality control review and promptly correct findings • Perform end-to-end case processing steps under supervision • Assist with administrative tasks related to pharmacovigilance systems, including preparing files, templates, and checklists • Provide administrative support for audits and inspections • Conduct weekly literature searches using predefined search strategies • Document search results, identify potential safety cases, and escalate them for assessment • Prepare data for Aggregate Safety Reports (PSURs/PBRERs), RMP/SMP sections, and risk minimization activities • Support Local Safety Officers in the DACH region to maintain compliant pharmacovigilance operations, with potential progression to Local Safety Officer

🎯 Requirements

• University degree or final-year student status in Life Sciences or a related field • Fluent written and verbal English and German • Foundational knowledge of pharmacovigilance principles and relevant regulatory frameworks • Ability to perform routine pharmacovigilance tasks accurately under supervision, including case intake, data entry, and literature review • Good computer literacy and ability to learn safety databases and pharmacovigilance systems • Good organizational skills and ability to manage a routine workload effectively • Strong attention to detail and accuracy in documentation • CV must be submitted in English

🏖️ 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 position • Rewarding referral policy • Workplace establishment allowance • Team building, global meetings, B active events