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

Safety Reporting Analyst

Location: 

Raleigh, North Carolina, United States

Job Function:  Drug Safety & Pharmacovigilance
Job ID:  64485

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?

 

To strengthen our Safety Reporting Team, based in our RTP Office in Raleigh, NC, we are looking for a talented individual to fill the position of: Safety Reporting Analyst.

 

As a Safety Reporting Analyst, you will be a part of the Safety Reporting team that meets the evolving Reporting & Analytics needs of UCB Patient Safety and provide high quality outputs responding to complicated / critical (including inspection / audit) ad hoc report requests utilizing Argus Safety and Business Objects. This function is key to our ability to analyze safety data and combines deep safety data knowledge with creativity and requires good communication with safety physicians and scientists.

 

You like to work in an environment where you can:

  • Be a self-starter with excellent pharmacovigilance knowledge and project management capabilities in pharmacovigilance who is seeking to be part of an innovative and fast-paced team to support the companys drug development activities.

 

You will contribute by:

  • Analyze and prioritize reporting requests and respond to complicated / critical ad hoc report requests using appropriate searches to retrieve relevant data
  • Optimize existing and defining search strategies in collaboration with Safety Leads/stakeholders
  • Analyze data extractions for quality check purposes and liaising with Case processing team for case completeness
  • Provide quality data extractions at short notice and support stakeholders during inspections / audits
  • Participate in standardized custom reports releases for review of business functionality with external vendor
  • Interacts across multiple functions and geographic locations and supports various internal and external stakeholders of the organization for reporting needs
  • Perform peer review checks for reports developed by team members
  • Other responsibilities may include lead / participation in initiatives / projects related to drug safety analysis and reporting from the business side (working with IT functions) from inception to delivery

 

Interested? For this position you’ll need the following education, experience and skills:

Minimum Qualifications:

  • Bachelors degree required, Masters degree preferred
  • Minimum of 5+ years of relevant Pharmacovigilance / drug safety or clinical reporting experience
  • Knowledge of Safety Databases (e.g. Argus / ARISg) is required, knowledge of reporting tools (e.g. SAP Business
  • Objects) and search strategies is preferred
  • Strong expertise regarding individual case safety report processing or analysis
  • Experience in computerized systems validation and Project Management is a plus
  • Knowledge of production of periodic/aggregate reports (PSUR/PBRER, DSUR, SMR etc.) is plus.
  • Knowledge of standard dictionaries like MedDRA & WHO Drug Dictionary is a plus
  • Excellent communication skills with a well-developed ability to efficiently and productively communicate both verbally and in writing, in a multi-cultural environment
  • Knowledge of non-structured data handling and obtaining data insights is a plus
  • Forward planning, proactive, ability to work independently and demonstrated capacity to simultaneously manage competing tasks and demands
  • Occasional International travel may be required

 

 

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

 

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

 

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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