Pharmacovigilance Assistant

About the Company

PrimeVigilance is a global leader in pharmacovigilance dedicated to advancing medicine by placing patient safety at the forefront of all operations. Our teams support clients through complex regulatory environments, from initial drug development to post-marketing drug safety surveillance. We focus not only on processing safety data but also on interpreting it to identify early signals and provide actionable insights.

Across multiple continents including Europe, North America, South America, Asia, and Australia, PrimeVigilance fosters a culture of kindness, flexibility, growth, and inclusion where every team member is valued and supported.

Role Overview and Key Responsibilities

• Handle receipt and acknowledgement of safety messages, ensuring accurate tracking and filing of Individual Case Safety Reports (ICSRs) adhering to regulatory, company, and client-specific requirements and timelines.
• Assist with miscellaneous administrative duties as needed.
• Manage ICSR processing focused on simpler cases such as solicited reports with limited data, minimal information reports, E2B format cases without narrative documentation, data cleansing, and standardized form reports.
• Provide support to the Regulatory Affairs and Pharmacovigilance Network Department, including acting as the Local Contact Person for Pharmacovigilance (LCPPV) for the assigned country and serving as the Person Responsible for Local Screening (PRLS) for the designated language, as coordinated with management.

Qualifications and Desired Skills

• Completion of high school or university degree.
• While experience is not mandatory, prior administrative experience is an advantage.
• Strong communication abilities.
• Proficient in English, both spoken and written at an advanced level.
• Advanced skills in computer literacy, especially Microsoft Office applications.

Additional Information

Joining Ergomed Group means contributing to bringing safe and effective pharmaceutical treatments worldwide. You will become part of a passionate, diverse, and collaborative team of clinical research, pharmacovigilance, and quality consulting experts. Our core values emphasize quality, integrity, drive, agility, inclusion, and teamwork.