Pharmacovigilance Inspection Management Lead F/M/X

MANTU GROUP SA; Belgique; Remote; EUR 90,000 - 120,000; Full time

Benefits offered by this job

International community

Training & Academy

WeCare Together program

Gym access

Lunch vouchers

Remote work 2 days/week

Job summary

Amaris Consulting, part of Mantu, is seeking a Pharmacovigilance Inspection Management Lead to support global PV inspections and ensure readiness. The role focuses on inspection readiness, documentation review, and collaboration with Regulatory, Clinical and other functions across PV operations.

You will host inspections, provide quality oversight of PV systems, and drive continuous improvement in inspection processes. English fluency is required; French is a plus.

Qualifications

• 5 to 8 years of experience in pharmacovigilance, GVP quality, or auditing.

Responsibilities

• Drive inspection readiness activities for global PV inspections.
• Collaborate with PV, Regulatory, Clinical and other functions.
• Review documentation to ensure GVP, GCP, GLP compliance.
• Support and host inspections including front/back room activities.
• Provide quality oversight on PV systems and processes globally.
• Prepare and support audit/inspection readiness and documentation review.
• Facilitate communication during inspection management.
• Contribute to continuous improvement of inspection management processes.

Skills

Inspection management

Pharmacovigilance

GVP compliance

Auditing

Regulatory liaison

Documentation review

Stakeholder management

English fluent

French is a plus

Tools

PV systems

Quality management systems

Vendors management

Job description

Pharmacovigilance Inspection Management Lead F/M/X

Other

The position is part of the Impact Quality team, supporting global pharmacovigilance (PV) activities and inspections. The main focus of this specific role is inspection management and inspection readiness, ensuring compliance with global regulatory requirements (GVP, GCP, GLP).

Your missions

• Drive inspection readiness activities for global pharmacovigilance (PV) inspections.
• Collaborate closely with internal stakeholders across PV, Regulatory, Clinical, and other functions.
• Review documentation and ensure compliance with global regulatory requirements (GVP, GCP, GLP).
• Support and host inspections, including front room and back room activities.
• Provide quality oversight on PV systems and processes globally.
• Prepare and support audit/inspection readiness and documentation review.
• Facilitate communication and coordination during inspection management.
• Contribute to continuous improvement of inspection management processes.

Your profile

• 5 to 8 years of experience in pharmacovigilance, GVP quality, or auditing
• Strong experience in inspection management
• Experience in pharmacovigilance inspections, ideally having hosted inspections
• Experience with global regulatory authorities: FDA, EMA, MHRA, etc.
• Solid background in GVP compliance and quality assurance
• Experience in audit and inspection readiness, including documentation review
• Experience with PV systems, vendors, and quality management systems
• Auditing experience: internal or external audits
• Experience in global and transversal environments
• English fluent. French is a plus.
• You demonstrate strong collaboration and stakeholder management skills

What we offer

• An international community bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Mantu, sustainability is part of everything we do. You'll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you'll be empowered to design and lead projects that create real social or environmental impact, with the company's full support.
• Benefits: access to our gym club, lunch vouchers and free language classes (if relevant)
• Remote policy: Possibility to work remotely 2 days per week (if relevant)

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We're focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.