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?
To strengthen our US Pharmacovigilance Operations in the Global Patient Safety unit, we are looking to fill the position of Drug Safety Officer to be based from our US Headquarters in suburban Atlanta, GA. Under supervision of the US Local Safety Leader, the Drug Safety Officer is responsible for ensuring the implementation of a compliant Pharmacovigilance (PV) system to safeguard public health and maintain compliance with applicable regulatory requirements.
Do you see yourself as the caring, scientific type? Did you know, at UCB you are known as a “carentific” person? This very special blend of talent means you are good a putting patients’ first while applying knowledge.
As a UCB 'carentific' person and Drug Safety Officer you like to work in an environment where you can:
- Proactively share knowledge with others.
- Take initiative and work towards creating patient value, rather than merely completing a task.
- Align efforts toward a common purpose to ensure maximum impact for patients.
- Generously offer help and resources to others in the interest of the business
As a UCB 'carentific' person and Drug Safety Officer you will contribute by:
- Serving as a Pharmacovigilance (PV) expert with respect to FDA PV requirements (commercial, regulatory, medical affairs, etc.) and independently make decisions regarding PV Operations
- Supporting routine PV Operations including daily oversight of internal and external staff, managing and updating the service provider specific SLA/KPIs, and monitoring the quality of service provider outputs.
- Serving as resource to both internal and external stakeholders on safety surveillance related activities for Global/US local products to ensure that all safety information is collected, reviewed, reported and benefit-risk assessments are performed as appropriate.
- Reviewing/approving safety surveillance deliverables: signal detection, benefit-risk and aggregate report documents/deliverables as prepared by the service provider for US local products
- Providing support and acting as a resource to in-house team in the review of patient programs, initiatives, studies, etc. to provide PV expertise and ensure proper controls are in place for PV impacted local/global programs.
Interested? For this position, you’ll need the following education, experience and skills:
- Bachelor’s/BSN degree (or higher) in a related medical field with sound knowledge of biomedical sciences and therapeutic principals (licensed professional with advanced degree preferred).
- 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 helpful
- Knowledge of FDA PV requirements
- Line management experience preferred
Discover more about the remarkable UCB Talent Blends and how you can contribute to the mix at www.ucb.com/careers .
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
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