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.
- Lead the Benefit Risk Team (BRT) activities, including signal detection, analysis, validation, risk management, and safety labelling.
- Contribute to clinical study teams, providing safety input for design, conduct, data analysis, and interpretation. May act as study-level Safety Lead.
- Support safety science interactions with partner companies, ensuring information sharing and collaborative functioning of the Joint Safety Management Team (JSMT).
- Drive monitoring, review, and evaluation of safety information, highlighting potential safety signals.
- Lead the preparation of periodic reports (e.g., PSURs and DSURs) and risk management plans (RMPs).
- Provide safety expertise for regulatory submissions, interactions, and product expansion activities.
- Contribute to the development and maintenance of safety-related systems, processes, and procedural documents.
- Support audits and inspections related to pharmacovigilance activities.
- Collaborate with cross-functional teams to ensure compliance with GVP, GCP, and worldwide regulatory requirements.
Education and Experience:
- University level qualification in biosciences, healthcare, or pharmacy; PhD preferred
- Minimum 3 years' post-graduation experience in pharmaceutical industry or regulatory agency
- Solid knowledge of pharmacovigilance regulations and cross-functional working
Skills and Knowledge:
- Proficiency in signal detection, risk management, and safety labelling
- Experience in preparing periodic safety reports and risk management plans
- High quality written and spoken English
- Strong analytical skills and attention to detail
- Thorough understanding of GVP, GCP, and worldwide regulatory requirements
Personal Attributes:
- Effective communicator and team player
- Sound judgement skills; able to assess and handle risks
- Problem solver with proven delivery focus
- Adaptable to fast-paced environments
- Commitment to patient safety and ethical practices
