Local Contact Person for Pharmacovigilance and Regulatory Affairs

📋 Description

• Prompt and effective communication with MAH and local regulatory authorities as required
• Primary contact person with local regulatory authorities for Regulatory Affairs and
• Provision of local regulatory intelligence screening and expert advice for the responsible region(s)
• Collection and reporting of locally suspected ADRs or ICSRs (FUs, translations)
• Local management / oversight of risk minimization measures related to urgent safety restrictions
• Support with development and implementation of local pharmacovigilance system in compliance with

🎯 Requirements

• Bachelor's Degree in Life Sciences or Chemistry, Nursing or equivalent professional experience
• At least 3 years of pharmacovigilance or safety-related experience in pharmaceutical, CRO, or
• Good understanding of ICH GVP and local pharmacovigilance requirements (training or practical
• Experience in case handling, literature screening, or local PV activities is preferred
• Prior experience in Regulatory Affairs is preferred but not mandatory
• Proficiency in English and additional language knowledge is advantageous