Manager, Pharmacovigilance Alliance - Safety Contracts

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Date: May 13, 2019

Location: Raleigh, US

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?

About UCB

Are you passionate about pharmacovigilance and the transparent communication which enables informed decision-making so every patient gets the right care?  Do you have an agile mind that enjoys being analytical?  For UCB, you are an ‘agilytical’ person.  This remarkable blend of talent enables you to swiftly apply forward thinking for the good of patients.  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 with a revenue of €4.530 billion in 2017.  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.

 

As a UCB 'agilytical' person and SDEA Manager you like to work in an environment where you can:

 

About the Role

As the SDEA Manager, you will collaborate with internal stakeholders and external business partners in the end-to-end lifecycle management of Safety Data Exchange Agreements (SDEA):

  • Lead the preparation, negotiation and conclusion of SDEAs relating to Development and Commercial partnerships.
  • Support the establishment and maintenance of SDEA related business processes, standards and systems.
  • Act as a key contact point on all matters relating to SDEAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) as well as external business partners.
  • Ensure oversight on all assigned SDEAs, contractual obligations and associated deliverables throughout the lifecycle of the partnership.
  • Ensure compliance with company guidelines, legal and regulatory requirements and industry practice.
  • Actively support audits and inspections as well as resolution of CAPAs.

 

About You

You should have:

  • Bachelor's degree is required, Master’s degree is preferred.  
  • At least 2 or more years’ experience in pharmacovigilance and/ or regulatory, quality, legal, contract management related role. 
  • Good working understanding of global clinical and pharmacovigilance regulations and guidelines.
  • Understanding of contractual concepts and terminology. Experience drafting, interpreting and managing agreements with business partners is a plus.
  • Strong negotiation and problem solving skills.
  • Effective time management skills and 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

 

 

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.     
  • Demonstrate a strong work ethic, decision making skills as well as tolerance to stress.

 

 

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


Nearest Major Market: Jackson Mississippi

Job Segment: Immunology, Purchasing, Pharmacovigilance, Law, Manager, Healthcare, Finance, Legal, Management

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