Drug Safety Physician
UCB – Inspired by patients. Driven by science.
Help us transform patients’ lives.

About UCB

At UCB, we put our heart, soul and skills into making a difference for people living with severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

To strengthen our Patient Safety Group, we are looking to fill the position of: Drug Safety Physician.

About the Role
You will be responsible for:

• Being one of the safety experts for their assigned products.
• Providing occasional training to project teams or at project related external meetings on medical issues or pharmacovigilance.
• Contributing to the scientific analysis and review of various sources of safety data using their knowledge of the regulations.
• Managing and overseeing the identification of risks and prioritizes the risks and mitigation actions that provide value for patients.
• Reviewing of appropriate data from product complaints database for patient safety implications.
• Reviewing and providing 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).
• Providing support to SL, Benefit Risk Team (BRT) for Global Labelling Committee (GLC), Benefit Risk Board (BRB), and PVU activities.
• Producing accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
• Managing the synthesis and interpretation of safety and epidemiological data, identifying insights that can be used to differentiate products and support decision making.

About You
You should have/be:

• Robust and comprehensive safety analyses experience of individual and aggregate data to support safety signal detection, evaluation, and management in the context of overall benefit risk balance.
• Valued expertise and input to life-cycle product teams.
• Decisive, appropriate input and responses to ad hoc safety issues.
• Viewed as a recognized expert on responsible product areas within the organization.
• Previous experience in Drug Safety coupled with the ability to work in matrix environment.  
• Formal training in analytic skills such as biostatistics or epidemiology, ideally.
• Project management experience and pre-clinical experience/knowledge.
• Clinical trial experience with prior experience in a relevant scientific field.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7 500 people in approximately 40 countries, the company generated revenue of € 4.6 billion in 2018. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news