Loading...
Share this Job
Apply now »

 

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

Manager Safety Data Exchange Agreement - UK Posting

Location: 

Slough, Berkshire, United Kingdom

Job Function:  Partnership & Alliance Management
Job ID:  64611

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 our pioneering adventure?

Manager, Safety Data Exchange Agreement

Slough, UK

Help us transform patients’ lives

About UCB

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 Patient Safety department, we are looking to fill the position of Manager, Safety Data Exchange Agreement role.

 

About the Role

  • You will manage the Safety Data Exchange Agreements as well as the Pharmacovigilance Agreements for contractual relationships with license business partners and act as key contact person for internal and external stakeholders. Managing the relationship directly throughout the lifecycle of the agreement, including compliance oversight.
  • 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 and communicate contractual obligations to internal stakeholders
  • Apply standardised 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 and actively support audits and inspections.
  • Work in integration with Regional Safety Liaisons, collaborating and co-developing projects, initiatives and activities aimed to improve, harmonise and ensure oversight of PV processes across local Affiliates and Partners worldwide.
  • Escalate issues utilising governance models and standard communication plans involving business partners.

 

About You

  • You should be educated to relevant degree level or the equivalent and have substantial experience in the pharmaceutical industry within Patient Safety. As well a good understanding of global drug safety regulations such as  FDA, EMA, MHRA, Bfarm, etc. and working in a global pharmaceutical Safety department.
  • A good 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.
  • Be experienced in the life-cycle of SDEAs including the development, implementation and compliance oversight for an array of business set-ups including manufacturer, Distributor, Supplier, Warehouse, Local MAH  Local Representative License-Out, License, Co-Development and Divestment.
  • Have the ability to critically analyse information and offer creative solutions based and be experienced in process improvement initiatives.

 

At UCB, growth and profitability constitute a guarantee for stability. You will always have the time and the backing needed to turn your ideas into reality. You can plan your future. We are building the next generation biopharma leader and need exceptional individuals to achieve this goal. We are looking for enthusiastic and talented professionals who thrive on challenge and change, and who want to make a difference and deliver results. Human talent is the greatest asset of our organization – we continue to strengthen our talent pool, our organization and, our ability to deliver.  

 

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With 7,500 people in approximately 40 countries, the company generated revenue of €4.6 billion in 2018. UCB is listed on Euronext Brussels. Follow us on Twitter: @UCB_news


Job Segment: Database, Medical, Law, Pharmacovigilance, Data Management, Technology, Healthcare, Legal, Data

Apply now »