Senior Pharmacovigilance Alliance Lead (Hybrid)

ProPharma Group; Leiden; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

ProPharma Group seeks a Senior Pharmacovigilance Consultant, Alliance Management, to implement and maintain alliance services for clients, including LPPV roles, LPPV networks, PSMF management, and SDEA/PVSA drafting.

The role involves coordinating cross-functional teams, supporting PV governance, and ensuring regulatory alignment across UK/EU while enabling patient safety and operational excellence.

Qualifications

• Education to a BSc or higher in life sciences or related discipline.
• At least 4 years in Clinical/Post Marketing Pharmacovigilance.
• At least 2 years in alliance management.
• Strong understanding of PV/regulatory landscape in the UK/EU.
• Excellent attention to detail and focus on quality.
• Proactive and positive approach.
• Very good written and oral communication skills.
• Solid planning, prioritizing and organizational skills.
• Able to liaise and negotiate with clients to ensure needs are met.
• Able to work in a team and manage multiple projects.

Responsibilities

• Coordinates and oversees LPPV networks, ensuring regulatory and client compliance, maintaining vendor oversight and performance, driving process improvements, and facilitating cross-team collaboration.
• Sets up and updates PSMFs and annexes to keep documentation accurate and current with regulatory and client requirements.
• Supports and maintains Alliance Management processes, identifying opportunities to enhance the process.
• Serves as an LPPV in accordance with the applicable Role Description.
• Drafts SDEAs on behalf of clients and partners, including review and negotiation, as well as PVSAs and SoWs between ProPharma and local PV providers.
• Drafts and/or reviews Pharmacovigilance Management Plans where Alliance Management is contracted.
• Supports client audits and inspections.

Skills

PV governance

Stakeholder management

Project management

Communication skills

Attention to detail

Negotiation

Team collaboration

Multi-project management

Education

BSc or higher in life sciences

Job description

ProPharma Group seeks a Senior Pharmacovigilance Consultant, Alliance Management, to implement and maintain alliance services for clients, including LPPV roles, LPPV networks, PSMF management, and SDEA/PVSA drafting.

The role involves coordinating cross-functional teams, supporting PV governance, and ensuring regulatory alignment across UK/EU while enabling patient safety and operational excellence.