Senior PV Study Lead

BioTalent; Greater London; Remote; GBP 40,000 - 60,000; Full time

Job summary

An innovative firm is seeking a fully remote Pharmacovigilance Operations Study Lead for a global pharmaceutical company. This exciting role involves overseeing case management, ensuring compliance with regulatory standards, and optimizing pharmacovigilance workflows. Candidates should possess a Bachelor’s degree in a health-related field and have a strong background in pharmacovigilance. Join this dynamic team to make a significant impact in drug safety while enjoying the flexibility of remote work. This position offers a high chance of extension beyond the initial contract period, making it a fantastic opportunity for career growth.

Qualifications

• Proven background in pharmacovigilance/drug safety.
• Strong understanding of global AE/ICSR regulatory requirements.

Responsibilities

• Lead processing and quality assurance of adverse event reports.
• Oversee vendor performance and ensure compliance through audits.

Skills

Analytical Skills

Communication Skills

Decision-Making

Attention to Detail

Organization

Time Management

Adaptability

Collaboration

Education

Bachelor’s degree in health-related or biological science

Tools

Microsoft Office

Safety Database Tools

Job description

Direct message the job poster from BioTalent

Recruitment Consultant - Account Management EU Contract

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Analyst and Science

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

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