PV Governance

5 days ago

Singapore Biocon Biologics Full time
As a Lead for PV Governance & Compliance in our Bangalore office, you will play a crucial role in overseeing Pharmacovigilance (PV) compliance within the clinical development and medical affairs organization. Reporting directly to the Head of Pharmacovigilance, your responsibilities will include ensuring adherence to global regulatory requirements, standard operating procedures (SOPs), work instructions, training, audits, inspections, and CAPA management.Your leadership skills will be essential as you collaborate with internal and external stakeholders, overseeing PV contracts, PV Single Drug Event Agreements (SDEAs), QPPV contract coordination, and Pharmacovigilance System Master File (PSMF) management.Key Responsibilities:- Monitor, report, and manage metrics and key performance indicators (KPIs) related to global pharmacovigilance compliance.- Ensure quality and compliance activities align with policies, guidelines, regulatory requirements, and standards globally and regionally.- Uphold high-quality and compliance standards across all processes with a focus on continuous improvement.- Oversee KPIs, reporting, and associated Corrective and Preventive Actions (CAPAs).- Manage Quality Management Plans and the Pharmacovigilance Safety Master File (PSMF).- Collaborate on PV service provider-specific SOPs, Work Instructions, and global PV-related documents.- Support deviation development within the Quality Management System (QMS) and associated CAPAs.- Stay updated on PV regulations for specific countries and regions.- Develop responses to audit and inspection reports, including CAPA implementation.- Participate in quality review meetings and analyze performance trends for ongoing improvement.- Lead Change Management Oversight and ensure vendor compliance with PV services.- Fulfill pharmacovigilance commitments to regulatory authorities regarding marketing authorization.- Lead audit and inspection readiness efforts and participate in regulatory inspections and audits.- Address audit findings and compliance issues through corrective and preventive actions.- Perform any other duties as assigned.Your role will be instrumental in maintaining PV compliance standards, driving quality improvement initiatives, and ensuring alignment with global regulatory requirements. Your proactive approach and strong communication skills will be crucial in successfully managing PV governance and compliance functions.,
  • Job Tags business process quality, quality assurance, capa, quality management, inspection
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