Safety Alliance Management Associate Job at UCB S.A.
Make your mark for patients
We are looking for a Safety Alliance Management Associate who will support the global Safety Alliance Management team and the maintenance of the Centralized Safety Agreements Management (CESAM) database based in our UCB Biosciences offices in Morrisville, NC.
About the role:
A qualified candidate will be responsible for managing the Centralized Safety Agreements Management (CESAM) database and related procedural documents.
What you’ll do:
- Act as the CESAM reference point of contact and ensuring accuracy and completeness on an ongoing basis – including data entry, quality checks, reconciliation with internal/ external stakeholders.
- Coordinate the communication of new/ updated SDEA requirements to internal stakeholders.
- Manage the distribution and tracking of SDEA deliverables.
- Support and/ or lead CESAM system and process improvement/ upgrade initiatives.
- Support audits, inspections and PSMF related requests.
- Manage the SAM team’s central mailbox, including addressing routine enquiries from internal operational teams.
- Manage low complexity SDEAs in accordance with UCB guidelines and regulatory requirements (e.g., preparation, negotiation, implementation, compliance oversight).
- Collecting data from internal stakeholders to support routine compliance meeting preparation.
Interested? For this role we’re looking for the following education, experience and skills:
- Good working understanding of global pharmacovigilance requirements. Familiarity with contractual concepts and terminology is a plus.
- Effective time management and organizational skills with the 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.
- Interest in developing SDEA expertise – proactive, motivated self-starter and fast learner.
- Ability to work autonomously.
- Ability to work within an international team environment.
- Ability to manage process updates in EDMS independently.
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!
About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.
Why work for us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.
Learn more about sustainability at UCB and how it is integrated into our business approach.
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/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
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