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Let's push the boundaries together and make the most of your talents!

Safety Physician

Location: 

Raleigh, North Carolina, United States

Job Function:  Clinical Development
Job ID:  65970

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

 

About UCB

At UCB, we put our heart, soul and skills into making a difference for people living with chronic disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

 

To strengthen our Global Patient Safety Group, in our RTP Office in Raleigh, NC, we are looking to fill the position of: Patient Safety Physician

 

About the Role

You will be required to:

  • Identify risks and propose corrective actions in moderately complex situations
  • Apply appropriate strategies and option based rationale
  • 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
  • Write and review response to questions from competent Authorities
  • When applicable, be responsible for risk-benefit assessment for assigned products
  • Coordinates key activities in safety communication in the scope of regular deliverables involving Patient Safety (benefit-risk assessment, results of clinical trials, safety signals and similar)
  • Reviews of appropriate data from product complaints database for patient safety implications
  • 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 PVU activities
  • Produce accurate and fit-for-purpose signal evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data,
  • Manages 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:

  • MD, PhD, PharmD, DVM or other relevant advanced degree
  • Minimum of 5 years relevant experience e.g. clinical development, pharmacovigilance.
  • Ideally 3 years experience in Drug Safety
  • Preference will be given to those individuals with excellent English scientific writing and communication skills
  • Ability to work in matrix environment
  • Formal training in analytic skills such as biostatistics or epidemiology
  • Project management experience
  • Clinical trial experience
  • Previous experience in a relevant scientific field

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

 

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.


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