Global Product Safety Scientist

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.

Qualifications : Required :

Desired :

Personal Attributes :

Remote Work : Yes

Employment Type : Full-time

Key Skills

Laboratory Experience,Immunoassays,Machine Learning,Biochemistry,Assays,Research Experience,Spectroscopy,Research & Development,cGMP,Cell Culture,Molecular Biology,Data Analysis Skills

Experience : years

Vacancy : 1