Deputy Local Safety Officer
Deputy Local Safety Officer
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Job Description
Make your mark for patients
We are looking for a Deputy Local Safety Officer to join us based in ShanghaiChina.
About the role
- Support and back up the LSO of China to ensure that Pharmacovigilance systems
operations and procedures are in place within the local organization for all territories
assigned to the Affiliate China - The individual is responsible for the oversight of a compliant Pharmacovigilance (PV)
system with Cinkate to safeguard public health and maintain compliance with applicable
regulatory requirements.
What youll do
- Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Patient Safety; EEAQPPVLSO
- Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office either directly or through local delegations (UCB colleagues or third parties); PSMFUCBEEA QPPV
- Implement and maintain a pharmacovigilance system for the UCB products authorized in the territory and ensure compliance with applicable regulatory and company requirements; UCB
- Work in close collaboration with corporate Patient Safety teams to ensure that local obligations are managed and compliance to local authorities is maintained;
- Provide input into global/local processes to secure compliance; /
- Maintain quality management system related to the pharmacovigilance including management of Standard Operating Procedures (SOPs) Associated Instructions (AIs) and documents (e.g. forms templates) to describe local processes and requirements and perform regular gap analysis as needed in order to ensure alignment with global SOPs; SOPAIsSOP
- Ensure timely management of deviations and risk mitigation by defining appropriate CAPAs and ongoing trend analysis as appropriate. CAPA
Interested For this role were looking for the following education experience and skills
- 4-5 years in Pharmacovigilance at minimumClinical Medicine Major
- Scientific background in Central Nervous System and/or immunology therapeutic areas helpful
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 8500 people in all four corners of the globe inspired by patients and driven by science.
Why work with us
At UCB we dont just complete tasks we create value. We arent 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 equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats 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.
UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Required Experience:
Unclear Seniority
Employment Type
Full Time
