Global Product Safety Specialist

2 days ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time
Job Overview

Sobi - Swedish Orphan Biovitrum AB (publ) is seeking a highly skilled Global Product Safety Specialist to join our team. As a key member of our Global Pharmacovigilance & Patient Safety (GPV), you will be responsible for providing scientific expertise to safety surveillance and risk management activities.

Responsibilities
  • Signal Detection and Evaluation: Provide scientific expertise to safety surveillance and risk management activities, including signal detection and evaluation for assigned products.
  • Clinical Safety Science Interactions: Contribute to clinical safety science interactions with partner companies for the product, ensuring effective sharing of safety information and collaborative functioning of the joint safety management team.
  • Safety Database Management: Create, extract, and prepare listings from data sources required for signal detection, safety surveillance/analysis, and regulatory submission activities.
Requirements
  • Education and Experience: University level qualification in biosciences, healthcare, or pharmacy. At least 3 years' experience post-graduation in the pharmaceutical industry, preferably in Patient Safety and/or Clinical/Drug Development, or at a regulatory agency.
  • Skills and Qualifications: Analytical skills, ability to work proactively, independently, and collaboratively with colleagues. Team-leadership capabilities, relationship builder, and effective communicator.


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