10% discount, use promo code: WDPILLS23
Saviours Pharma Consultancy Limited provides pharmacovigilance, Risk Management Plan and safety governance support for pharmaceutical organisations, healthcare businesses, specialist consultancies, CROs, service providers and strategic partners requiring senior input across post-marketing safety systems, affiliate PV governance, inspection readiness and regulatory compliance.
Pharmacovigilance System Governance
We support the design, review and strengthening of pharmacovigilance systems, including affiliate PV responsibilities, UK and EU PSMF alignment, National Contact Person arrangements, QPPV oversight interfaces, SOP architecture, role definitions, escalation pathways and documented operational responsibilities. Our work helps organisations move from informal or partially documented processes towards a structured, auditable and inspection-ready PV framework.
Risk Management Plans and Follow-up Activities
Support may include review and implementation of Risk Management Plan commitments, targeted follow-up questionnaires, additional pharmacovigilance activities, risk-minimisation measures, safety concern tracking, trigger criteria, version control of follow-up forms, follow-up attempt rules, data storage requirements and alignment between RMP obligations, SOPs, training and operational workflows.
ICSR, Adverse Event and Safety Escalation Processes
We support the review and improvement of adverse event receipt, recording, assessment and escalation processes, including ICSR access routes, safety information received through Medical Information, customer service, social media, product complaints, healthcare professional enquiries and patient communications. This includes ensuring that valid, invalid, incomplete or follow-up safety information is appropriately identified, documented and escalated within required timelines.
Inspection Readiness, Audit and CAPA Support
We provide support for pharmacovigilance audit preparation, mock inspection planning, inspection-readiness packs, document availability checks, CAPA trackers, deviation logs, finding classification, evidence-of-closure requirements and management review preparation. This service helps organisations identify gaps before inspection and convert findings into practical corrective and preventive actions with clear ownership and traceable closure evidence.
Technical Agreements, SDEAs and Service Provider Oversight
We support the review of pharmacovigilance responsibilities within technical agreements, safety data exchange arrangements, distributor due diligence, service-provider registers, PV-related contract oversight, legislative monitoring arrangements and documented interfaces between marketing authorisation holders, affiliates, distributors, service providers and commercial partners.
Training, SOPs and Cross-Functional Safety Awareness
We support development and review of PV SOPs, affiliate procedures, training matrices, role-based PV training, SOP read-and-understand processes, refresher training, safety escalation awareness and cross-functional links with Medical Information, Regulatory Affairs, Quality, GDP, ABPI/compliance, commercial teams and senior management. This ensures that personnel understand how to identify, record and escalate safety information appropriately.
Anonymised Programme Experience
Selected anonymised experience includes supporting affiliate pharmacovigilance governance, UK PSMF and annex review, SOP alignment, NCP role clarification, RMP implementation planning, targeted follow-up questionnaire workflows, product document control, ICSR access mechanisms, out-of-hours PV contact arrangements, technical agreement review, training matrix development, CAPA planning and inspection-readiness improvement.
Engagement Models
This service is particularly relevant for organisations requiring senior pharmacovigilance input, affiliate PV system review, RMP implementation support, inspection-readiness preparation, CAPA remediation, SOP development, NCP or QPPV support interfaces, safety governance review, associate consultant support or subcontract PV compliance delivery across UK, European, Gulf and international healthcare markets.
