Description

In this role, you will work closely with the Global Product Safety Science Lead to shape the Safety Science strategy for Sobi products. Your day-to-day responsibilities will involve collaborating with multidisciplinary teams, preparing safety reports, and ensuring compliance with regulatory standards.

Requirements

• •University level qualification in biosciences, healthcare, or pharmacy
• •Minimum 3 years' post-graduation experience in pharmaceutical industry
• •Advanced knowledge of pharmacovigilance regulations
• •Excellent written and spoken English
• •Strong analytical and problem-solving skills
• •Effective communication and team leadership capabilities
• •Experience in process development, implementation, and oversight
• •Proven delivery within a matrix safety team
• •Problem solver with a proven delivery focus
• •Effective team player

Tasks

• •Collaborate with the Global Product Safety Science Lead to develop and implement the Safety Science strategy for assigned products
• •Contribute to the operation of the product level multidisciplinary Benefit Risk Team, including signal detection and risk management
• •Provide clinical safety input to study teams, potentially serving as study level Safety Lead
• •Support the creation and maintenance of core and EU Risk Management Plans
• •Lead the preparation of periodic safety reports and contribute to benefit-risk assessments
• •Monitor and evaluate incoming safety information to identify potential safety signals
• •Contribute to regulatory submissions and product safety information in various documents
• •Liaise with external service providers to ensure strategic alignment and timely delivery of Safety Science documents
• •Support product-specific case management guidance and respond to medical safety inquiries
• •Participate in literature reviews and contribute to worldwide literature review strategies
• •Support audits and inspections related to product safety