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Safety Data Exchange Agreement Associate

Location: 

Raleigh, North Carolina, United States

Job Function:  Partnership & Alliance Management
Job ID:  64767

 

 

Associate, SDEA
Raleigh, NC
Help us transform patients’ lives

 

About UCB
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. 

 

To strengthen our Safety Data Exchange Agreement (SDEA) management team, we are looking to fill the position of: Associate, SDEA . 

 

About the Role
You will be responsible for:
•    Managing the Centralized Safety Agreements Management (CESAM) database
•    Acting as the CESAM reference point of contact and ensuring accuracy and completeness on an ongoing basis – including data entry, quality checks, reconciliation with internal/ external stakeholders
•    Coordinating the communication of new/ updated SDEA requirements to internal stakeholders
•    Managing the distribution and tracking of SDEA deliverables 
•    Supporting and/ or leading CESAM system and process improvement/ upgrade initiatives
•    Supporting audits, inspections and PSMF related requests
•    Managing the team’s central mailbox, including addressing routine enquiries from internal operational teams
•    Managing low complexity SDEAs in accordance with UCB guidelines and regulatory requirements (e.g. preparation, negotiation, implementation, compliance oversight)

 

About You
You should have:
•    Bachelor's degree is required 
•    Good working understanding of global pharmacovigilance requirements. Familiarity with contractual concepts and terminology is a plus
•    Effective time management and organizational skills with the ability to manage potential shifts in priorities
•    Excellent oral and written communication skills - proficient in English
•    Good analytical skills and attention to detail 
•    Strong team orientation and ability to work autonomously in a cross-functional and cultural environment 
•    Interest in developing SDEA expertise – motivated self-starter and fast learner


What We Offer
An opportunity to:
•    Be part of a dynamic team interacting with a wide array of stakeholders
•    Contribute to the enhancement of UCB’ SDEA management processes, systems and standards
•    Be part of an environment that encourages personal and professional growth through collaboration, sharing best practices and lessons learned
 

 

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system.

With more than 7500 people in approximately 40 countries, 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.


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