Loading...
Share this Job
Apply now »

 

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

Safety Data Management Lead

Location: 

Raleigh, North Carolina, United States

Job Function:  Drug Safety & Pharmacovigilance
Job ID:  65128

Safety Data Management Lead

UCB Biosciences

Raleigh, NC or Atlanta, GA

About UCB

 

UCB is a multinational biopharmaceutical company headquartered in Brussels, Belgium with a revenue of €4.632 billion in 2018.  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.

 

At UCB, we put our heart, soul and skills into making a difference for people living with severe 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?

 

Help us transform patients’ lives.

 

To strengthen our Safety Data department, we are looking to fill the position of: Safety Data Management Lead. You will be either based in our Atlanta or Raleigh offices in the US. Please ensure that you apply to the correct posting (this one is for US application.

 

As UCB Safety Data Management Lead, you like to work in an environment where you can:

  • Utilize your pharmacovigilance and safety system experience in order to add value in our Data Safety Insight department
  • Deliver impactful results in our high-performance culture
  • Use an agile collaboration approach in cross-functional teams.

 

 

Your role summary

 

Your key mandate as Safety Data Management Lead is to develop and optimize safety business processes in alignment with safety system functionalities to ensure quality, compliance and integrity of single safety case handling.

You will oversee case processing of clinical trial, post-marketing solicited and spontaneous individual case safety reports by identifying regulatory changes and assessing their impact on current processes; communicating any necessary actions up to management as well as to the operational processing centers; and assist in driving projects that improve the use of systems in adverse event reporting and submissions

 

As a member of our Safety Data Insight team, you will effectively communicate information with regards to adverse event reporting, training, process improvements, and regulatory changes in the pharmacovigilance industry across functional teams and to external partners.

 

Your key accountabilities

 

  • Serves as subject matter expert on adverse event reporting and submission within patient safety and other cross functional areas
  • Leader in the review and implementation of robust communication and interfacing processes with PV outsourcing and strategic initiative partners to ensure all outsourcing activities meet business and regulatory objectives
  • Provides pharmacovigilance expertise and insight on process improvements and able to initiate discussions with manager for implementation of any necessary actions
  • Enhances overall quality of ICSRs by overseeing completion of various activities that contribute to the compliance of ICSRs, including case processing delivery,  system implementation and validation, and working with the other teams including but not limited to QC team, safety physicians, local safety officers, clinical project teams and external vendors as needed
  • Write and maintain SOPs regarding ICSRs. Provide insight and initiate any changes needed due to changing business need, system requirements, or regulatory changes.
  • Provides oversight and delegation of all received e-mails within the team mailboxes
  • Able to coordinate, motivate, and lead small teams/workstreams within Safety Data Insights (SDI) for the successful completion of tasks and address any applicable issues that may hinder completion of deliverables within Patient Safety (PS)
  • Able to communicate within PS and across departments in technical/scientific language to generate discussion on issues or regulatory changes but also able to communicate complex topics and information in layperson's terms as needed
  • Anticipates risks and develops solutions independently
  • Provides backup for the Head of Safety Data Management, when needed.
  • Provides training to internal and external partners as needed
  • Able to deliver presentations or reports to senior management, departmental teams, or industry audiences in a clear, relaxed, and proficient manner
  • Performs other tasks as deemed necessary by the department and Company

 

 

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

 

Your experience

 

  • You built a solid experience in the pharmaceutical industry with experience in pharmacovigilance department or a clinically-oriented discipline, including significant experience in the conduct of clinical studies and/or experience in the compilation or the analysis of aggregate safety data.
  • You gained at least 5 years’ experience in safety case processing as per PV regulations in both clinical and post-marketing settings. Experience in safety database systems with knowledge of query strategies is a plus. You worked with quality assurance departments in quality improvement initiatives and have knowledge of how to implement case processing improvements.

 

Your profile and skills

 

  • In order to be successful in this role, you must have leadership qualities in leading other team members or teams.
  • You can demonstrate excellent organisational, inter-personal, diplomatic, and leadership skills.
  • You recognize yourself as a logical thinker with meticulous attention for detail while maintaining an overall view. You combine a strong scientific sense with a responsible attitude.
  • You developed good written and oral communication skills, fluency in English
  • You gained a thorough and expert knowledge of not only pharmacovigilance theory, regulations, and application but also of safety systems (Argus) and how pharmacovigilance fits into the larger scope of the drug development cycle
  • Your knowledge of regulatory pharmacovigilance requirements and use of query tools or databases constitutes will be an asset.
  • You excel in problem solving and proactively identify the issues requiring solutions
  • You enjoy collaboration, your are a good team player, helpful and generous to others
  • You use your ability to think ‘outside of the box’ to propose innovative solutions

 

What we offer

 

UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB. Would you like to join a strong team that wants to make a real difference in immunology and neurology?

 

Working in Data Safety Insight at UCB you’ll utilize your extensive expertise to contribute in teams that are laser-focused on creating value for people living with severe disease. Are you the impactful manager we are looking for?

 


Job Segment: Manager, Neurology, Database, Immunology, Data Management, Management, Healthcare, Technology, Data

Apply now »