Senior Pharmacovigilance Consultant, Alliance Management

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

The Senior Pharmacovigilance Consultant, Alliance Management, implements and maintains Alliance Management services for ProPharma clients, such as covering the role of a Local Contact Person Responsible for Pharmacovigilance (LPPV), coordinating LPPV networks, maintaining the Pharmacovigilance System Master FIle (PSMF), managing Pharmacovigilance Services Agreements (PVSAs)/Safety Data Exchange Agreements (SDEAs).

• locations: Leiden; Sweden; Stockholm; Ireland; Bulgaria (DNU); View All 10 Locations
• time type: Full time

Essential functions:

• Coordinates and oversees LPPV networks, ensuring compliance with regulatory and client requirements, maintaining vendor oversight and performance, driving process improvements, managing stakeholder engagement, supporting PV governance activities, and facilitating effective communication and collaboration across teams to promote patient safety and operational excellence;
• Sets up and performs routine updates of PSMFs and associated annexes, ensuring documentation remains accurate, current, and aligned with regulatory and client requirements;
• Supports and maintains the Alliance Management processes within ProPharma, identifying opportunities to develop and enhance the process where appropriate;
• Serves as an LPPV in accordance to the applicable Role Description;
• Drafts SDEAs on behalf of clients and with client’s contractual partners, including their review and negotiation, as well as PVSAs and Statements of Work (SoWs) between ProPharma and its local pharmacovigilance service providers;
• Drafts and/or reviews Pharmacovigilance Management Plans (or equivalent documents) where Alliance Management services are being contracted;
• Supports client audits and inspections.

Necessary Skills and Abilities:

• Must have been educated to a BSc or higher within a life-sciences or industry related discipline
• At least 4 years or more working in Clinical/Post Marketing Pharmacovigilance
• Must have at least 2 years experience working in alliance management
• Thorough understanding of the PV/Regulatory landscape within the UK/EU
• Excellent attention to detail and focus on quality;
• Proactive and positive approach;
• Very good written and oral communication skills;
• Sound planning, prioritizing and organizational skills;
• Very good decision making and problem-solving skills;
• Able to liaise and negotiate efficiently with clients to ensure the client needs are met;
• Able to work within a team in an open and professional manner;
• Ability to manage multiple projects.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.