Senior Specialist PV Regulatory Intelligence

Job Description:

Responsibilities

• Ensure compliance of global ICSR distribution by correct distribution rule set-up in the Safety Database. This includes :
• Regular monitoring of regulatory information system.
• Regular review of distribution requirements received from ASRs
• Perform plausibility checks and impact analysis of changes in regulations and ensure implementation of distribution rules in Safety Database
• Contact person for ASRs for redistribution of cases, updates of distribution rules, contacts, products, timelines and local requirements in the Safety database
• Contact person for ICSR reporting requirements for other GPV groups, e.g. Case Processing, QPPV, Compliance, Safety Database Operations
• Act as deputy ICSR Distribution Coordinator
• Perform regulatory reporting to EMA
• Monitor Global Safety database Submission section for received/failed acknowledgements

Qualification & Experience

• Master in Science, Ph.D. in Life Sciences, B.E. or B.Tech or equivalent Excellent