Pharmacovigilance Inspection Management Specialist F/M/X

Job Description

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).

• 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.

Job Description

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).

• 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 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, dis