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 Safety Science strategy for assigned Sobi products.
- Participate in and support the Benefit Risk Team (BRT) to drive signal detection, analysis, risk management, and safety labeling.
- Contribute to clinical study teams, providing safety input for design, conduct, data analysis, and interpretation. May serve as study-level Safety Lead.
- Support the creation and maintenance of safety documentation, including Safety Management Plans, Risk Management Plans (RMPs), and periodic reports (e.g., PSURs, DSURs).
- Monitor, analyze, and evaluate incoming safety information to identify potential safety signals.
- Provide safety expertise for regulatory submissions, interactions, and product expansion activities.
- Collaborate with cross-functional teams to ensure compliance with GVP, GCP, and worldwide regulatory requirements.
- Contribute to the development and maintenance of safety-related systems, processes, and procedural documents.
- Support audits and inspections related to product safety.
- Review scientific literature and contribute to worldwide literature review strategies.
Required:
- University level qualification in biosciences, healthcare, or pharmacy. PhD in a relevant topic preferred.
- Minimum 3 years' post-graduation experience in the pharmaceutical industry, preferably in Patient Safety and/or Clinical/Drug Development, or at a regulatory agency.
- Advanced knowledge of pharmacovigilance regulations and cross-functional working.
- Excellent written and spoken English.
- Strong analytical and problem-solving skills.
- Effective communication and team collaboration abilities.
- Experience in process development, implementation, and oversight.
Desired:
- Proven delivery within a matrix safety team.
- Team leadership capabilities.
Personal Attributes:
- Proactive problem solver with a strong delivery focus.
- Effective team player with sound judgement and decision-making skills.
