TEAM LEAD – CLINICAL SAFETY & PHARMACOVIGILANCE (CSPV)
Location: Noida, India
Employment Type: Full-Time
Experience Required: 6–10 Years
Department: Clinical Safety & Pharmacovigilance
POSITION SUMMARY
The Team Lead – Clinical Safety & Pharmacovigilance (CSPV) is responsible for leading pharmacovigilance operations, ensuring compliance with global regulatory requirements, managing project delivery, and overseeing team performance. The role requires strong leadership capabilities, extensive pharmacovigilance knowledge, and the ability to manage multiple projects while maintaining quality, compliance, and operational excellence.
The incumbent will serve as a key point of contact for internal teams, clients, and regulatory stakeholders while ensuring the successful execution of pharmacovigilance activities in accordance with applicable regulations and client expectations.
KEY RESPONSIBILITIES
Pharmacovigilance Project Leadership
Ensure effective functioning of assigned pharmacovigilance projects.
Oversee project execution in compliance with client agreements, regulatory requirements, and internal procedures.
Monitor project deliverables to ensure adherence to timelines, quality standards, and compliance requirements.
Drive operational excellence across all assigned PV activities.
Project Management & Ownership
Take ownership of assigned projects and operational deliverables.
Ensure timely completion of project milestones and client commitments.
Monitor project performance metrics and identify improvement opportunities.
Escalate project risks and operational challenges to management when necessary.
Quality & Compliance Management
Ensure compliance with:
Global Pharmacovigilance Regulations
Client Agreements
Internal Quality Standards
Industry Guidelines
Manage quality, compliance, and documentation across assigned projects.
Support implementation of quality improvement initiatives and CAPA activities.
Team Leadership & People Management
Provide line management and leadership to assigned team members.
Delegate tasks and responsibilities effectively.
Monitor team performance and productivity.
Conduct performance reviews and provide constructive feedback.
Foster a culture of accountability, collaboration, and continuous improvement.
Training & Mentoring
Train and mentor team members to enhance technical and professional skills.
Identify training and development requirements.
Support onboarding and capability-building initiatives.
Promote knowledge-sharing across the department.
Stakeholder Management
Collaborate with:
Clients
Internal Functional Teams
Quality Teams
Regulatory Stakeholders
Ensure effective communication regarding project status, risks, and compliance matters.
Build and maintain strong professional relationships with stakeholders.
Audit & Inspection Support
Represent the department during:
Internal Audits
Client Audits
Regulatory Inspections
Support audit preparation and inspection readiness activities.
Address audit observations and support CAPA implementation.
Ensure documentation remains inspection-ready.
Documentation & SOP Management
Author, review, and maintain:
Standard Operating Procedures (SOPs)
Work Instructions
Compliance Documents
Departmental Guidelines
Ensure documentation complies with regulatory and quality requirements.
Resource & Workload Management
Monitor team capacity and departmental workload.
Ensure optimal resource utilization.
Escalate staffing or workload concerns to the Functional Head when necessary.
Support workforce planning and operational efficiency initiatives.
REQUIRED KNOWLEDGE & TECHNICAL EXPERTISE
Pharmacovigilance Knowledge
Strong understanding of:
Pharmacovigilance Operations
ICSR Case Processing
Adverse Event Reporting
Clinical Safety Reporting
Signal Management Concepts
Post-Marketing Surveillance
Global Safety Regulations
Regulatory Knowledge
Working knowledge of:
FDA Regulations
EMA Regulations
ICH Guidelines
Good Pharmacovigilance Practices (GVP)
Good Clinical Practice (GCP)
Global Drug Safety Requirements
Leadership & Management Skills
Team Leadership
Performance Management
Resource Planning
Project Management
Stakeholder Engagement
Conflict Resolution
Decision Making
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