Safety Data Exchange Agreement Manager

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Date: Mar 13, 2019

Location: Slough, Berkshire, GB

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 severe diseases. We look to transform patients’ lives by pushing the boundaries of what is possible. With us, our talent makes the most of who they are, unlocking innovation and setting new standards for patients.

 

Everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” And to find the answers, we connect globally with patients and their families living with the physical and social burdens of severe disease. These connections give us new perspectives, drive our innovation, and offer a hope for a new generation of therapies that will help to transform lives.

 

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.

 

With more than 7500 employees in approximately 40 countries, we are a global biopharmaceutical company headquartered in Brussels, Belgium which invests more than 25% of revenue in cutting-edge scientific research to meet unmet patient needs. A few other reasons that make UCB an amazing place to work:

 - Promising pipeline that includes several novel molecules and no major patent expiration in the next decade;

 - About 25% of 2016 revenue reinvested into Research & Development

 - 2016 Key Financials: €4.2 billion global revenue Specialties: Neurology, Immunology

 


Job Segment: Database, Neurology, Immunology, Pharmacovigilance, Law, Healthcare, Technology, Legal

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