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Global Product Safety Scientist
Global Product Safety ScientistSobi • Munich, Bavaria, Germany
Global Product Safety Scientist

Global Product Safety Scientist

Sobi • Munich, Bavaria, Germany
Vor 30+ Tagen
Stellenbeschreibung

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:

  • 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


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
Jobalert für diese Suche erstellen

Global Product Safety Scientist • Munich, Bavaria, Germany

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