Clinical Trial Scientist (m/f/d)
Sobi
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.
Collaborate with the Global Product Safety Science Lead (GPSSL) to develop and implement the Safety Science strategy for assigned Sobi products.
Contribute to clinical study teams, providing safety input for design, conduct, data analysis, and interpretation. Support safety science interactions with partner companies, ensuring information sharing and collaborative functioning of the Joint Safety Management Team (JSMT).
Contribute to the development and maintenance of safety-related systems, processes, and procedural documents.
Collaborate with cross-functional teams to ensure compliance with GVP, GCP, and worldwide regulatory requirements.
PhD preferred
Minimum 3 years' post-graduation experience in pharmaceutical industry or regulatory agency
Solid knowledge of pharmacovigilance regulations and cross-functional working
High quality written and spoken English
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