Manager, Safety Data Exchange Agreement:

Raleigh North Carolina

Help us transform patients' lives.

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 this pioneering adventure?

Nature and Scope of Position:

Manages Safety Data Exchange Agreements (SDEA)/Pharmacovigilance Agreements (PVA) for contractual relationships with license business partners and acts as key contact person for internal and external stakeholders, managing the relationship directly throughout the lifecycle of the agreement (creation/negotiation, implementation and maintenance) including compliance oversight.


Major Accountabilities:


  • Act as a Safety contact point on all matters relating to Safety agreements with license business partners including the handling of confidential information and negotiation of the agreements with commercial and co-development partners. 
  • Coordinate the preparation and conclusion of SDEAs together with relevant internal and external parties.
  • Track and maintain oversight on all assigned Safety agreements.
  • Support and liaise on local country deals with UCB local affiliate offices.
  • Communicate contractual obligations to internal stakeholders in a clear and comprehensive manner.
  • Apply standardized contract guidelines in-line with company polices and legal and regulatory constraints.
  • Ensure oversight and respect of contractual obligations with all internal and external parties for all SDEAs.
  • Ensure compliance with PV regulations, guidelines and industry practice.
  • Actively support audits and inspections.
  • Work in integration with Regional Safety Liaisons, collaborating and co-developing projects, initiatives and activities aimed to improve, harmonize and ensure oversight of PV processes across local Affiliates and Partners worldwide.
  • Escalate issues utilizing governance models and standard communication plans involving business partners.




  • Experience with life-cycle of SDEAs (development, implementation and compliance oversight) for an array of business set-ups including manufacturer, Distributor, Supplier, Warehouse, Local MAH (per local legislation) Local Representative (delegation of PV activities), License-Out, License, Co-Development and Divestment.
  • 3-5 years’ experience in pharmaceutical industry, with at least 2 years in Patient Safety; knowledge of the drug development processes and pharmacovigilance obligations including GVP, ICSR Reporting, Periodic Safety Reports (PADER, DSUR, PSUR/PBRER), RMP and Safety Surveillance activities.
  • Experience with global drug safety regulations (i.e., FDA, EMA, MHRA, Bfarm, etc.) and working in a global pharmaceutical Safety department.
  • Motivated self-starter with strong team orientation.
  • Strong project management skills.
  • Organized and structured.
  • Good analytical skills.
  • Proficient in English - Excellent reading and writing skills.
  • Excellent computer skills (Word, PowerPoint, Excel).
  • Flexible to changing priorities and challenging timelines.


Management and Leadership Skills


  • Strong negotiations skills.
  • Result-oriented.
  • Effective time management skills and ability to manage potential shifts in priorities.
  • Commitment to quality, integrity and reliability.
  • Experience in managing/mentoring junior staff.


Delivering Solutions


  • Critically analyzes information and offers creative solution based on expertise and following consultation with peers, manager and subject matter experts resulting in win-win solutions.
  • Experience with process improvement initiatives.


Sphere of Influence


  • Looks for opportunities when facing a problem; willingness to challenge constructively and respectively.
  • Discusses issues with Manager honestly and openly.
  • Ability to effectively communicate and comprehend technical issues.




  • Bachelor degree required.
  • Master degree preferred.


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 living with severe disease.

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.  Thinking holistically, working together, championing change, delivering impactful results…these are some of the key competencies we are constantly developing, and looking for, at UCB.

UCB and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer.  Minority/Female/Disability/Veteran

Basic Qualifications