Head of Safety Data Exchange Agreements:
UCB

53123-en_US
UCB
Raleigh North Carolina
Pharmaceutical
Description

Leads and manages the SDEA Management team. Accountable for ensuring the existence of global Pharmacovigilance standards (procedures, instructions, templates and tools) for the management of PV commercial and co-development partnerships. Maintain oversight of SDEA partnership with the establishment of KPls to monitor SDEA obligations and alignment with current pharmacovigilance regulations. Proactive strategic planning to ensure optimization of efficient processes and resources. Collaboration with external and internal functions throughout the lifecyle of the contract.

 

Major Accountabilities:

 

  • Accountable for the preparation and conclusion of safety agreements together with the legal department, between business partners and UCB.
  • Support and liaise on local country deals with UCB affiliates and Regional Safety organizations.
  • Standardized safety agreements frames in line with company standard, legal and regulatory constraints.
  • Ensuring appropriate communication of PV and Legal contractual obligations to internal stakeholders in a manner clear and comprehensive for non-legal staff.
  • Acting as a Safety contact point for the legal and commercial departments on all PV matters, including the handling of confidential information and negotiation of Pharmacovigilance files.
  • Ensuring appropriate processes and tools are implemented to maintain oversight and respect of pharmacovigilance contractual obligations with all internal and external partners for all contracts.
  • Escalate non-compliance to pharmacovigilance contractual obligations and ensure they are appropriately managed.
  • Ensure compliance with the Safety/Legal Regulations and standards industry practice in contracts and advise on how the global pharmacovigilance department should implement these.
  • Actively lead/participate in External Network Governance meeting.
  • Actively support audits and inspections.
  • Work in integration with the Regional Safety Liaisons, collaborating and co-developing projects, initiatives and activities aimed to improve, harmonize and ensure oversight of PV processes across Affiliates and Partners worldwide. Lead or collaborate on ad hoc ro•ect needs.

 

Education and Experience:

 

  • Bachelor's degree
  • Knowledgeable in the area of Pharmacovigilance (5 to 8 years' experience, ideally), including the interpretation and application of pharmaceutical regulations and SDEAs.
  • Good leadership, managerial and organizational skills.
  • Ability to work in cross-functional, inter-departmental working groups in a worldwide environment.
  • Ability to handle a number of numerous projects simultaneously is essential.
  • Good sense of responsibility, accurate and independent work style, and organizational talent.
  • Ability to work under time pressure and high commitment.
  • Team player with the ability to provide leadership, good person interaction skills, influencing without authority, good organizational and presentation skills, high degree of motivation.
  • Good communication skills.
  • Motivation and proactive management style.
  • Fluent in English.
  • Good leadership and entrepreneurial skills
  • Self-management skills.
  • Excellent reading and writing skills.
  • Organized and structured. Excellent computer skills.
  • Strong negotiation skills.
  • Effective time management skills and ability to manage potential shifts in priorities. Flexible to changing riorities and challen in timelines.
Basic Qualifications
Requirement