The Global Product Safety Scientist (GPSS) is responsible for providing safety scientific expertise and works with the Global Product Safety Science Lead (GPSSL) to develop and implement the Safety Science strategy for assigned Sobi products. The GPSS works collaboratively together with the GPSSL and other members of the Sobi Global Pharmacovigilance team, together with other functions across Sobi, to ensure that safety science activities are delivered to ethical and safety quality standards to ensure safety of patients, and compliance with GVP, GCP and worldwide regulatory requirements.
Key Responsibilities:
- Collaborate with the Global Product Safety Science Lead (GPSSL) to develop and implement the Safety Science strategy for assigned Sobi products.
- Contribute to the operation of the product level multidisciplinary Benefit Risk Team (BRT), including signal detection, analysis, validation, risk management, and safety labelling.
- 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 (RMPs).
- Lead the preparation of periodic safety reports (e.g., PSURs and DSURs) and contribute to benefit-risk assessments.
- Monitor, review, and evaluate incoming safety information to identify potential safety signals.
- Contribute to regulatory submissions, interactions, and product safety information in various documents.
- Liaise with external service providers to ensure strategic alignment and timely delivery of Safety Science owned documents.
- Support product-specific case management guidance and contribute to responses for medical safety enquiries.
- Participate in literature reviews and contribute to worldwide literature review strategies.
- Support audits and inspections related to product safety.
Required:
- University level qualification in biosciences, healthcare, or pharmacy; PhD preferred
- Minimum 3 years' post-graduation experience in pharmaceutical industry, preferably in Patient Safety or Clinical/Drug Development
- Advanced knowledge of pharmacovigilance regulations and cross-functional working
- Excellent written and spoken English
- Strong analytical and problem-solving skills
- Effective communication and team leadership capabilities
- Experience in process development, implementation, and oversight
Desired:
- Proven delivery within a matrix safety team
Personal Attributes:
- Problem solver with a proven delivery focus
- Effective team player
