Patient Safety Scientist

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our global Patient Safety and Medical Management (PSMM) group we are looking for a talented individual to fill the position of Patient Safety Scientist.

As a Patient Safety Scientist, you will have the following responsibilities:

• 
  Be one of the safety experts for assigned products
• Contributes to the scientific analysis and review of various sources of safety data (eg, regulatory, clinical, submission, legal, product quality) using knowledge of the regulations
• Manages and oversees the identification of risks and prioritizes the risks and mitigation actions that provide value for patients
• Liaise with local safety officers (LSOs) and other affiliated personnel on responses to local authorities
• Coordinates key activities in safety communication in the scope of regular deliverables involving PSMM (benefit-risk assessment, results of clinical trials, safety signals and similar)
• When applicable, provide safety input and review to aggregate reports and ad hoc safety reports
• When applicable provides input into pharmacovigilance process improvement (eg, assigned member of process workstreams)
• Review and provide safety input for relevant clinical or regulatory documents for assigned products (IB, protocols, RMP, SmPC, US PI, PIL, EMA article 31s, FDA field alerts, and OSS/Recall Medical Assessments, etc)
• Provide support to SL, Benefit Risk Team (BRT) for Global Labelling Committee (GLC), Benefit Risk Board (BRB), and PVS/EBU activities
• Produce accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data
• Uses quantitative and qualitative methods to obtain relevant information about stakeholders’ needs, motivations and behaviors in order to contribute to the generation of insights

About you

You should have:

• 
  PhD or PharmD preferred
• Skilled at operating in cross- cultural team environment
• Able to understand and analyze clinical and medical data
• High level of knowledge of pharmacovigilance and risk management science
• Knowledge and understanding of applicable regulations in pharmacovigilance and clinical development
• Demonstrates proactivity in maintaining compliance of own actions with PV regulations and PV system.
• Able to effectively utilizes technology for high quality, consistent and efficient safety data capture, processing and analysis

About us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.