Local PV Support Person, Medical Information Specialist - Freelance

This is a fully remote position, open to applicants in Iceland.

📋 Description

• Execute local pharmacovigilance operations while ensuring adherence to safety regulations and procedures.

• Oversee Individual Case Safety Reports (ICSRs) and Follow-ups (FUs).

• Examine local literature relevant to pharmacovigilance.

• Analyze and review local legislation pertaining to drug safety.

• Conduct pharmacovigilance training sessions for Marketing Authorization Holder (MAH) employees.

• Address Medical Information Requests effectively.

• Assist Biomapas clients with various pharmacovigilance-related activities.

• Supervise daily operations, ensure compliance, exchange safety information, and act as a point of contact for timely safety processing.

• Work in close collaboration with local safety officers in the Nordic region and medical information specialists.

⛳️ Requirements

• A degree in Medicine, Biomedicine, Pharmacy, or Nursing.

• Proficient in both written and spoken English, with native fluency in Icelandic.

• Ideally, a minimum of 2 years of experience in pharmacovigilance.

• Comprehensive and proven experience in various aspects of pharmacovigilance and related legislation.

• Strong understanding of local and international regulations (ICH, EU GVP Modules).

• Possess analytical skills to comprehend, analyze, interpret, and present scientific data.

• Capability to interpret and apply both global and local drug safety regulations.

• High enthusiasm for personal development and learning within the team.

• Please submit your CV in English.

🏝️ Benefits

• Competitive salary and compensation package.

• Opportunities for professional development and training.

• Collaborative and supportive work environment.