Clinical Safety Project Lead

vor 2 Wochen


Wien, Wien, Österreich Octapharma Vollzeit

Job Title: Clinical Safety Project Lead

Company: Octapharma

Your New Career Opportunity:

  • Ensure the effectiveness and safety of clinical trials by coordinating safety management tasks across multiple company sites and studies
  • Act as a lead for Safety Medical Experts, aligning and coordinating their activities and those of other stakeholders in safety management tasks
  • Standardize safety reporting activities, review study protocols for compliance with safety regulations, develop new EDC and Safety Database integration processes, and enhance safety procedures
  • Provide input at CRO clinical bid defense meetings and oversee preparation of study safety reporting plans
  • Develop and implement CR&D processes in anticipation of new Safety Database, ensuring a global overview of timelines and status
  • Coordinate triage of SAE from clinical trials, expedited safety reporting to EMA, and submission of IND safety reports to FDA
  • Oversee SAE reconciliation, PV narrative writing processes, and post-marketing safety listings review
  • Report directly to the Head of CR&D in Vienna

Your Qualifications:

  • University Degree in natural or clinical sciences
  • Several years of experience in clinical safety management
  • Experience in the pharmaceutical industry, preferably in safety management
  • Knowledge of global clinical safety regulations and reporting requirements
  • Strong project management skills and excellent communication abilities
  • Fluency in English, German is a plus
  • Willingness to travel internationally

Benefits You'll Get:

  • Wide range of tasks in an international environment
  • Reliable employer with generous benefits
  • Familiar setting of a family-owned enterprise with unique staff benefits

Additional Details:

The minimum gross wage for this role is EUR 3.909,67 per month, but we are willing to offer higher wages based on your profile and tasks

We are excited to welcome dedicated employees to join us in promoting growth to improve patient lives - it's in our blood, is it in yours too? Apply through our online career portal

About Octapharma

Octapharma is a leading human protein manufacturer, dedicated to producing human proteins for patient treatment worldwide. With extensive experience in patient care, Octapharma operates globally across three therapeutic areas: Immunotherapy, Haematology, and Critical Care.



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