Pharmacovigilance Specialist

🔥 4 minutes ago

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Biomapas

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Act as a Local Safety Officer and Medical Information Specialist in Romania (nomination as per local requirements) • Communicate with Health Authorities • Ensure compliance with applicable local guidelines and regulations • Collect, process, and communicate of safety information, product quality complaints and medical device incidents • Maintain and establish quality standards for local pharmacovigilance activities • Ensure weekly monitoring of local literature review • Participate in inspection and/or audits • Ensure the survey and monitoring of national pharmacovigilance regulations • Receive and handle medical information enquiries from patients and health care professionals

🎯 Requirements

• Biologist, Pharmacist, Medical Doctor, or other life science degree • 2-year experience in Pharmacovigilance • Fluent in English and Romanian languages • Computer literacy (MS Office), experience with PV databases • Strong organizational and time management skills • Ability to work independently and in a team

🏖️ 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 • Team building, global meetings