דרושים » רפואה ופארמה » Regulatory Affairs Specialist

Requirements:
Manage the companys safety surveillance activities for products under clinical development, including case processing, periodic safety data assessments, signal detection, literature reviews, preparation and coordination of internal safety committees, and maintenance of an overall safety surveillance plan. Develop, maintain, and deliver training on internal PV SOPs and safety procedures, ensuring alignment with evolving regulatory requirements. Review/contribute to safety content for clinical and regulatory documents, including IBs, protocols, ICFs, CSRs, and DSURs. Execute and manage Safety data Exchange Agreements (SDEA) with partners for post-marketing products. Support and manage clinical trial operations activities throughout the clinical study lifecycle.