PV/SDEA - Safety Alliance Manager (REMOTE OR OFFICE BASED) at UCB Inc. in Raleigh, North Carolina

Job Description:

JOB DESCRIPTION

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen our Patient Safety Team, based in our RTP Office in Raleigh - Durham, NC or Home Based, we are looking for a talented individual to fill the position of: PV/SDEA - Safety Alliance Manager.

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

• Lead the preparation, negotiation and conclusion of SDEAs/ PVAs relating to Development and Commercial partnerships.


• Support the establishment and maintenance of SDEA/ PVA related business processes, standards and systems.


• Act as a key contact point on all matters relating to SDEAs/ PVAs 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/ PVAs, 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 3 years' experience in pharmacovigilance, regulatory, quality, legal, contract management and/ or compliance related role. 


• Good working knowledge of global clinical and pharmacovigilance regulations and guidelines. General understanding of the functional requirements for all critical pharmacovigilance processes.


• Good understanding of contractual concepts and terminology. Experience drafting, interpreting and managing agreements with business partners is preferred.


• Strong critical thinking/ analytical skills and attention to detail.


• Good negotiation and problem-solving skills.


• Effective time management skills and ability to adapt to changing priorities.


• Excellent oral and written communication skills - Proficient in English.


• Strong team orientation, experience and ability to work in a cross-functional and cross-cultural environment.


• Self-starter and ability to work autonomously.

** CAN BE REMOTE OR OFFICE BASED **

Why you should apply

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you'll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees - just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.