Principal Safety Officer

Make your mark for patients

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our global Patient Safety and Medical Management (PSMM) group, we are looking for a talented individual to fill the position of Principal Safety Officer based in our U.S. UCB Headquarters in the Greater Atlanta, GA area offices OR remote in nature.  We offer a hybrid working model.

You like to work in an environment where you can:

• Serve as a PV expert with respect to FDA PV requirements to commercial, regulatory, medical affairs, etc. and be able to independently make decisions regarding PV Operations
• Support routine Pharmacovigilance Operations which includes, but not limited to, engagement with internal/external stakeholders, providing daily oversight of global PV service provider activities, attending monthly partner touchpoint meetings (as required) and escalating any compliance related issues to the International PhV Ops team. Ensure oversight and timely completion of QC related activities.
• Support audits and inspections and demonstrate proficiency in RCA and CAPA Plan management.
• Review, interpretation, and analysis of trends in QC/US Safety Metrics data in order to draw meaningful conclusions and provide feedback to management, and other stakeholders as needed.
• Serve as resource to both internal and external stakeholders on safety surveillance related activities for Global/US local products and work with these stakeholders to ensure that all safety information is collected, reviewed, reported and benefit-risk assessments are performed as appropriate.
• Championing change as required to ensure a favorable benefit risk profile for UCB products.
• Provide support as a product liaison and review/provide input into local and/or ad hoc safety deliverables as required.
• Ensure local procedures are up to date and aligned with global procedures to maintain a compliant PV system.
• Perform regulatory intelligence by monitoring the US regulatory environment, taking steps to lead and initiate workstreams and involve all necessary stakeholders, etc.to ensure timely implementation of new requirements.
• Maintenance and development of SDEAs including partner due diligence, implementation, and ensure oversight for partnerships managed by the US Affiliate.

You will contribute by:

• Providing oversight on monthly updates of the PSMF with respect to US specific items to ensure inspection readiness.
• Collaborating with internal and external stakeholders and provide necessary feedback to improve quality of safety data and adherence to UCB procedures.
• Interfacing with multidisciplinary teams to ensure safety input is provided and liaise with Patient Safety.
• Managing the review of patient value programs/initiatives, studies, etc. to provide PV expertise and ensuring proper controls for PV impacted local/global programs are in place.
• Ensuring oversight of Patient Value initiatives, of PV relevance, throughout their lifecycle.
• Participating in review of safety sections for US clinical study protocols in conjunction with the PS Safety Leads in accordance with applicable procedures as required.
• Contributing to Labelling Review Committee activities for assigned products and/or therapeutic area.
• Maintaining relevant product and disease state knowledge regarding UCB’s products.
• Adhering to patient confidentiality and HIPPA requirements.
• Maintaining knowledge of policies and procedures including Standard Operating Procedures, protocols, best practices, and FDA regulations.

Interested? For this position you’ll need the following education, experience and skills:

Minimum experience:

• Bachelor’s/BSN degree (or higher) in a related medical field with sound knowledge of biomedical sciences and therapeutic principals.
• 5+ years Drug Safety, Medical Information or Pharmaceutical related experience of which 4 years must be in Drug Safety.
• Scientific background in CNS and/or Immunology.
• Thorough knowledge and understanding of FDA PV requirements.
• Demonstrated project management experience.

Preferred experience:

• Licensed professional with advanced degree preferred.
• Line management experience preferred.

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.