Safety Lead:
UCB

52822-en_US
UCB
Atlanta Georgia
Pharmaceutical
Description

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, we are looking to fill the position of: Safety Lead

About the Role

You will be responsible for:

  • Ensuring that the benefit risk assessment is current and that any changes are as per UCB’s governance principles. The patient safety for UCB products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe through the effective and timely completion of PV Assessment activities through product development, product maintenance and life cycle management.
  • Representing all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and reporting back relevant information regarding status, issues, challenges
  • Accountability and leading, in a matrix structure, the Benefit and Risk activities and ensuring signal detection, risk management, mitigation plans, safety analyses in aggregate reports. As well as scientific review of safety related information within in time lines and accuracy of the safety information in responses to Health Authorities, product labelling and investigator brochures. 

About You

You should have:

  • An MD/PhD/PharmD qualification or the equivalent
  • Substantial experience within the pharmaceutical industry as well as a proven track record in scientific and project team leadership. Along with a good understanding of the global pharmacovigilance and safety requirements for non-clinical development, the registration process and onto the market.
  • Good knowledge of relevant regulations and proven evidence of effective delivery of high quality documents. As well as relevant concepts in data management and systems, epidemiology and statistics
  • The ability to understand science and biology and understand the significance of preclinical findings when planning use in man. Act without oversight in most circumstances as well as provide key input to difficult or sensitive projects
  • Be able to identify risks and propose corrective actions in complex and critical situations and the ability to a multifunctional team as well basic project management skills to allow management and delivery of multiple complex deliverables within tight timelines
  • The technical skills and capabilities to author and contribute to large complex documents within document management systems and the knowledge of relevant concepts in health care, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
  • Have expertise and good knowledge of all  phases from FIM to post approval and relevant legislations and guidelines

What We Offer

An opportunity to:

  • Provide guidance and advice in complex and critical situations in a leadership capacity concerning safety, risk management and pharmacovigilance . As well as strategic advice based on expertise and thorough understanding of business implications
  • Be recognised as an expert on responsible product areas within the organization. And provide expertise and input to life-cycle product teams
  • Demonstrate a strong work ethic, decision making skills as well as tolerance to stress
  • Showcase your approach to building a inter departmental safety sub team, teamwork and developmental skills of subordinates both direct indirect

     

 

Basic Qualifications
Requirement