Pharmacovigilance Specialist

🔥 3 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

• Perform local operations and ensure compliance with safety regulations and procedures • Manage and share safety information with relevant authorities and clients • Serve as the main contact for safety matters with authorities and clients • Ensure timely handling of safety information for products • Review local literature • Medical Information Requests handling

🎯 Requirements

• Degree in Medicine, Biomedicine, Pharmacist or Nurse • Fluent written and spoken English and at least one of the following languages: Swedish, Norwegian or Danish • At least 2 years’ experience with Local pharmacovigilance activities in Nordics • 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

🏖️ Benefits

• Professional growth and career opportunities • International team and environment • Bonus based on annual performance • Personal accident and business trip insurance • Influenza vaccines • Rewarding referral policy • Workplace establishment allowance • Flexible working hours • Team building, global meetings, B active events