COMPLIANCE LEAD – CLINICAL SAFETY & PHARMACOVIGILANCE
Location: Noida, India
Employment Type: Full-Time
Experience Required: 5–8 Years
Department: Clinical Safety & Pharmacovigilance / Quality & Compliance
POSITION SUMMARY
The Compliance Lead – Clinical Safety & Pharmacovigilance is responsible for ensuring operational, regulatory, quality, and IT compliance across assigned pharmacovigilance projects. The role involves oversight of compliance activities, audit and inspection readiness, training management, quality documentation, adverse event processing oversight, and continuous process improvement initiatives.
The position serves as a key liaison between internal teams, clients, and regulatory stakeholders to ensure adherence to global pharmacovigilance regulations, company policies, quality standards, and contractual obligations.
KEY RESPONSIBILITIES
Compliance & Quality Oversight
Ensure compliance across assigned projects covering:
Operational Compliance
Regulatory Compliance
Quality Management Systems
IT Compliance Requirements
Support ongoing adherence to industry regulations and quality standards.
Monitor compliance metrics and identify areas requiring corrective action.
Ensure implementation of quality and compliance initiatives across projects.
Pharmacovigilance Operations
Record and review Adverse Drug Reactions (ADRs) and safety data within safety databases.
Support post-marketing and clinical trial safety reporting activities.
Ensure case processing activities comply with:
Regulatory requirements
Client agreements
Internal SOPs
Global Pharmacovigilance standards
Maintain high levels of accuracy, consistency, and quality in safety data management.
Project Governance & Compliance Management
Take ownership of assigned compliance projects and deliverables.
Ensure project timelines and quality standards are consistently achieved.
Monitor project documentation for completeness, accuracy, and regulatory compliance.
Identify compliance risks and recommend mitigation strategies.
Escalate quality or operational concerns to management when necessary.
Audit & Inspection Readiness
Support departmental audit and inspection activities.
Participate in:
Internal Audits
Client Audits
Regulatory Inspections
Quality Assessments
Coordinate audit preparation activities and documentation reviews.
Assist with CAPA (Corrective and Preventive Action) development and tracking.
Represent the department during audits and inspections as required.
Training & Development
Support training compliance across assigned functions.
Train and mentor team members on compliance requirements and best practices.
Identify skill gaps and recommend training programs.
Maintain training documentation and compliance records.
Contribute to onboarding and continuous learning initiatives.
Process Improvement & Operational Excellence
Support continuous process improvement initiatives.
Identify opportunities to enhance quality, efficiency, and compliance.
Participate in compliance monitoring programs.
Drive implementation of best practices and lessons learned.
Stakeholder Management
Collaborate with:
Internal Teams
Clients
Vendors
Quality Assurance Functions
Regulatory Stakeholders
Ensure compliance with contractual agreements and regulatory obligations.
Communicate project status, compliance risks, and mitigation plans effectively.
Documentation & SOP Management
Author, review, and update:
Standard Operating Procedures (SOPs)
Work Instructions
Compliance Documentation
Quality Management Documents
Training Materials
Ensure document control and version management processes are followed.
Maintain inspection-ready documentation at all times.
REQUIRED KNOWLEDGE & TECHNICAL EXPERTISE
Pharmacovigilance Knowledge
Strong understanding of:
Adverse Event Processing
ICSR Management
Clinical Safety Reporting
Post-Marketing Surveillance
Pharmacovigilance Operations
Safety Database Management
Regulatory & Compliance Expertise
Working knowledge of:
ICH Guidelines
GVP (Good Pharmacovigilance Practices)
FDA Regulations
EMA Regulations
Global Pharmacovigilance Regulations
Quality Management Systems (QMS)
GCP (Good Clinical Practice)
Quality & Audit Management
Experience in:
Audit Readiness
Inspection Management
CAPA Management
Compliance Monitoring
Risk Assessment
Quality Documentation Review
Systems Knowledge
Experience with one or more of the following:
Argus Safety
ARISg
Veeva Safety
Oracle Safety Systems
Learning Management Systems (LMS)
Quality Management Systems (QMS)
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