Company Description
DrugCard provides an AI-powered platform designed to streamline pharmacovigilance processes such as global and local literature monitoring, regulatory tracking, and case management. Trusted by pharmacovigilance teams worldwide, DrugCard ensures compliance and enhances efficiency through automation and actionable insights. With coverage of over 121 countries and 2200+ local journals, their platform simplifies drug safety monitoring and regulatory updates. Offering simple, intuitive tools and expert services, DrugCard empowers professionals to prioritize patient safety and strategic decision-making while reducing manual effort.
Role Description
This is a full-time remote role for a Drug Safety Specialist. The Drug Safety Specialist will manage adverse event reporting, ensure compliance with regulatory requirements, and support the operation and automation of pharmacovigilance processes. Additional responsibilities include monitoring literature and regulatory updates, assisting with safety case management, and collaborating with internal and external teams to maintain high standards of safety and compliance.
Qualifications
- Understanding of Regulatory Requirements and experience in Regulatory Affairs
- Strong background in Pharmacy and Medicine
- Experience in Clinical Trials and knowledge of their processes
- Excellent organizational, analytical, and problem-solving skills
- Strong written and verbal communication skills
- Proficiency in tools and systems related to pharmacovigilance and regulatory documentation
- Bachelor's or advanced degree in Life Sciences, Pharmacy, or a related field
- Experience in pharmacovigilance or related fields is highly advantageous
Key areas of responsibility
- To assure timely local and international medical literature monitoring for drug safety
- issues
- To assure timely processing and reporting of safety information in relation to contractual
- partner’s medicinal products
- To assure compliance with the Local and International Quality Management System
- To interact and exchange relevant safety information with local Competent Authorities
- and contractual partners
Main tasks and functions
