Our client, a global pharmaceutical organization, is looking for an Impact Quality Lead to implement and maintain a balanced, proactive approach to pharmacovigilance compliance. This role provides leadership across post-marketing programs and ensures that all safety activities meet international regulatory standards and industry best practices.
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Maintain global quality oversight of the pharmacovigilance system and the pharmacovigilance quality management system.
Provide expert guidance on
GVP
and
GCP
regulatory expectations, including
FDA ,
EMA, and
ICH
standards.
Oversee patient-centric initiatives and phase IV studies, ensuring data integrity during signal detection and risk management.
Lead and host
GVP
audits and health authority inspections, managing remediation plans and audit findings.
Manage vendor and partner compliance through the monitoring of
KPIs, metrics, and quality control checks.
Drive deviation management processes, including root cause analysis,
CAPA
implementation, and effectiveness evaluations.
Ensure the quality and compliance of safety outputs such as
ICSRs ,
DSURs ,
RMPs, and
REMS .
You have a Bachelor's degree in Life Sciences, Science, or Engineering.
You bring 8+ years of experience in
GVP
quality assurance,
GVP
auditing, or pharmacovigilance within the biotech or pharmaceutical industry.
You possess expert knowledge of global regulatory requirements including
GVPs ,
GCP ,
FDA ,
MHRA, and
ICH
guidelines.
You have experience managing quality assurance systems, including
CAPA ,
deviation management, and
audit
processes.
You're able to lead process improvement initiatives and work effectively within international, transversal environments.
You have strong analytical and conceptual skills with a high attention to detail.
You are fluent in
English .
Nice to Have
Master's degree in a scientific discipline. xphnsxz
Experience with
Veeva Systems
and the
Argus
global safety database.
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