Pharmacovigilance Specialist – Medical/Clinical Safety

🔥 1 minute ago

🌐 Bulgaria, Croatia, +3 more countries – Remote

🇧🇬 Bulgaria – Remote 🇭🇷 Croatia – Remote 🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇬🇷 Greece – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Specialist

👻 Ghost score 10%

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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

• Assure compliance with the Quality Management System • Process ICSRs and Serious Adverse Events from clinical trials, including safety database entry, tracking, narrative writing, site follow-up requests, quality checks/review, and reporting to clients or agencies • Perform reconciliation of safety data • Participate in Project/Study Team meetings as the Safety and Pharmacovigilance representative • Oversee planning, coordination, and quality review of aggregate safety reports • Support preparation and submission of regulatory safety documents, including DSURs and 6MLL • Supervise local handling, preparation, and submission of Periodic Safety Update Reports and Risk Management Plans and risk minimization activities • Collaborate with medical, safety physicians, data management, IT, and other functions to ensure timely and accurate reporting or report delivery • Act as Biomapas and/or contractual partners’ 24/7 local pharmacovigilance contact person or backup • Monitor national and regional pharmacovigilance regulations • Collect and process medical enquiries received through phone, email, fax, or other means • Support weekly monitoring of local or global literature review • Support continuous safety profile monitoring, detection of new signals, and evaluation • Participate in inspections and audits, including post-inspection/audit support, when required

🎯 Requirements

• University degree in the Life Science field • At least 4+-years’ experience in Pharmacovigilance, clinical safety and clinical development and expert knowledge of pharmacovigilance legislation • Knowledge of international regulations (ICH, EU GVP Modules, FDA) • Experience working with PV databases (e.g., Argus, ArisG) and MedDRA coding • Ability to interpret and apply global drug safety regulations • Fluent English and local country language • Eager to adopt automations and new technologies in daily tasks • Attention to detail, time-management and problem-solving skills • Project management experience is beneficial

🏖️ 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 • Influenza vaccines • Rewarding referral policy • Workplace establishment allowance (fully remote) • Team building, global meetings, B active events