Safety Specialist

Vor 2 Tagen

Wien, Österreich CSL Behring Vollzeit

About the Role:

We are seeking a skilled Safety Specialist to join our Global Safety and Pharmacovigilance department at CSL Behring. As a key member of our team, you will be responsible for managing local pharmacovigilance systems in compliance with national regulations and company policies.

Your Key Responsibilities:

  • Pharmacovigilance Oversight: Ensure comprehensive oversight of all local pharmacovigilance activities conducted at CSL, establishing a robust framework for assessing potential risks, monitoring trends, and managing emerging issues.
  • Risk Management: Identify, evaluate, and mitigate risks associated with product safety, ensuring compliance with regulatory requirements and company policies.
  • Communication and Collaboration: Establish good working relationships with Global Safety and Pharmacovigilance, Regulatory Affairs, and local functions, such as Quality Assurance and Clinical Research.
  • Training and Development: Manage PV training requirements of affiliate personnel and third-party service providers, ensuring they are aware of their PV reporting obligations.
  • Audit and Inspection Preparation: Ensure audit/inspection preparation and close-out activities, including the development of CAPA plans and closure of action items.

Your Skills and Qualifications:

  • Bachelor's degree in life science, nursing, pharmacy, or related area; or equivalent experience.
  • Qualification in line with relevant local legislation.
  • Experience in the pharma industry and knowledge in pharmacovigilance; or equivalent experience in line with relevant local legislation.
  • Good verbal and written communication skills in English.
  • Fluent in local language(s) of territory if required by legislation.

What We Offer:

  • An estimated annual salary of approximately €80,000 - €110,000, depending on qualifications and experience.
  • Excellent benefits package, including hybrid working models, extended leave days, and family services.
  • Opportunities for career growth and professional development in a global organization.

About CSL Behring:

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

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