Senior PV Study Lead

JR United Kingdom; Greater London; Remote; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Senior Pharmacovigilance Study Operations Lead for a fully remote role. This position focuses on managing adverse event reports and ensuring compliance with global regulatory standards. The ideal candidate will have a strong background in pharmacovigilance, vendor management, and process optimization. You'll collaborate with clinical teams and lead operations, making a significant impact in a dynamic environment. This role offers a chance to contribute to critical safety data oversight and process improvements, with the potential for extension beyond the initial contract period.

Qualifications

• Proven background in pharmacovigilance/drug safety with global AE/ICSR knowledge.
• Experience in vendor management and supporting audits/inspections.

Responsibilities

• Lead processing and quality assurance of adverse event reports.
• Oversee vendor performance and ensure compliance through training.
• Prepare safety documentation for regulatory submissions.

Skills

Analytical Skills

Communication Skills

Decision-Making

Attention to Detail

Time Management

Education

Bachelor’s degree in health-related or biological science

Tools

Microsoft Office

Safety Database Tools

Job description

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Senior Pharmacovigilance Study Operations Lead

We are currently looking for a fully remote Pharmacovigilance Operations Study Lead for a global pharmaceutical company on a 9 month contractual basis. This is a fully remote role with a high chance of being extended.

Key Responsibilities

• Case Management & Safety Data Oversight
• Lead the processing, review, and quality assurance of adverse event reports (ICSRs), ensuring compliance with global regulatory standards and internal protocols.
• Vendor and Compliance Management
• Oversee vendor performance in case processing, monitor KPIs, ensure quality control, and support compliance through training and regular audits.
• Process Optimization & Systems Support
• Improve pharmacovigilance workflows and systems by identifying process enhancements and contributing to SOP and policy development.
• Regulatory & Safety Reporting
• Prepare safety documentation for regulatory submissions, manage safety data accuracy, and respond to regulatory queries and audits.
• Cross-Functional Collaboration & Leadership
• Act as a liaison with clinical teams, mentor case management staff, support inspections, and lead operations in the manager’s absence.

Candidate Requirements

• Education: Bachelor’s degree in a health-related or biological science field (required).
• Experience:
• Proven background in pharmacovigilance/drug safety, with strong understanding of global AE/ICSR regulatory requirements.
• Familiarity with safety databases, MedDRA coding, and medical terminology.
• Experience managing vendor relationships and supporting audits/inspections.

Skills:

• Strong analytical, communication, and decision-making abilities.
• High attention to detail, organization, and time management.
• Proficient in Microsoft Office and safety database tools.
• Adaptable, collaborative, and capable of working in a dynamic environment.
• Willingness to work flexible hours as needed.