Your new role
• Take the leadership role in clinical project by providing drug safety oversight.
• Have project BD needs.
• Review and provision of medical opinion on various reports regarding drug safety prepared within the legal framework of pharmacovigilance.
• Answer Medical Information queries.
• Primary medical expert in addressing safety signal and actions for risk mitigation and management.
• Primary author for the safety sections of IB, clinical study protocol, clinical study report, and eCTD safety summary documents.
• Primary author and point of contact with external stake holder for DSUR.
• Conduct safety signal detection on a routine basis and develop methods for risk mitigation when needed.
What you'll need to succeed
• Medical Master a must, Medical Doctoral regress preferred.
• Practice in medicine and knowledge in drug development.
• Good understanding in regulatory requirements and ICH/GCP for safety reporting and pharmacovigilance.
• Good baseline knowledge of scientific literature retrieval and valuation (mainly using PubMed and EMBASE).
• Self-motivated and willing to contribute to patient safety.
• Excellent organization skills with attention to detail.
• Excellent interpersonal and communication skills.
• Fluent in written and verbal English.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1236058