Safety Reporting Analyst - US, UK or Belgium

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Date: Mar 18, 2019

Location: Braine L'alleud, Walloon Brabant, BE

Safety Reporting Analyst – US, UK or Belgium

Help us transform patient lives

 

Are you passionate about pharmacovigilance and the transparent communication which enables informed decision-making so every patient gets the right care?  At UCB, working at the forefront of scientific innovation, we put our heart, soul and skills into making a difference for people living with chronic disease. Working together to push the boundaries, we harness our passion, emerging technologies and blend the best of our talents to unlock innovation. Will you join us in our pioneering adventure?

 

UCB is a multinational biopharmaceutical company headquartered in Brussels, Belgium.  The Company's efforts are focused on research and development of treatments for severe diseases treated by specialists, particularly in the fields of central nervous system (CNS) disorders (including epilepsy) and immunology.

 

Job Description

The Safety Reporting Analyst is 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.

 

Major Accountabilities:

  • 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


Desired Skills and Experience

  • Bachelor’s degree required, Master’s 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

 


Job Segment: Pharmacovigilance, Immunology, ERP, Inspector, Healthcare, Technology, Quality, Research

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