Product Safety Lead Pharmacoepidemiology

2 days ago


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

The Global Product Safety Scientist has a key role within Global Pharmacovigilance & Patient Safety (GPV) and is responsible for providing scientific expertise to safety surveillance and risk management activities. The role actively contributes to setting the strategic direction within GPV and to the development of safety standards and processes.

Key Responsibilities
  • Safety Surveillance and Risk Management: 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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