When pharmacovigilance pressure builds, expert support matters

You’re expected to stay compliant, inspection-ready, and in control, even as regulations evolve, resources stay tight, and systems grow more complex. This is where iVigee’s pharmacovigilance consultancy support makes a difference

Guidance shaped by how pharmacovigilance is actually assessed.

When you’re making PV decisions, you need guidance grounded in how regulators assess pharmacovigilance in practice, not just how it’s written. iVigee’s consultants include physicians, former regulators, EU QPPVs, and industry leaders whose experience across inspections, audits, and regulatory interactions ensures the guidance you receive focuses on what truly matters when it counts.
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Why you might need pharmacovigilance consultancy support

Pharmacovigilance rarely slows down; the pressure just shifts. You’re expected to stay compliant and inspection ready as regulations evolve, resources tighten, and systems grow more complex. One moment it’s inspection prep; the next it’s findings, vendor changes, or decisions with real regulatory and patient-safety risk.

You don’t need more documentation or generic advice. You need clarity on what truly matters, confidence your decisions will stand up to scrutiny, and support from someone who understands both the regulations and the reality of running PV day to day. That’s where the right consultant makes the difference.

Pharmacovigilance rarely slows down; the pressure just shifts. You’re expected to stay compliant and inspection ready as regulations evolve, resources tighten, and systems grow more complex. One moment it’s inspection prep; the next it’s findings, vendor changes, or decisions with real regulatory and patient-safety risk.

You don’t need more documentation or generic advice. You need clarity on what truly matters, confidence your decisions will stand up to scrutiny, and support from someone who understands both the regulations and the reality of running PV day to day. That’s where the right consultant makes the difference.

Meet our
pharmacovigilance experts

Every PV challenge is different. iVigee consultancy connects you with specialists who bring real-world experience across the full PV lifecycle, so you can work directly with the expert best suited to what you’re facing.
Jan Petracek, MD

Jan Petracek, MD

Founder & Pharmacovigilance Consultant

Known for

Helping organizations focus on what truly matters in pharmacovigilance and patient protection.

Experience highlights

Former regulator and EU QPPV with global PV leadership experience

Built and transformed PV systems across start-ups, biotech, and global pharma

PV Strategy & Leadership

Risk Management & Signal Oversight

EU QPPV Oversight

PV System Design & Transformation

Inspection & Audit Readiness

Henry Seto, MD

Henry Seto, MD

Medical Safety & Pharmacovigilance Consultant

Known for

Bringing clinical judgment and operational clarity to medical safety and PV decisions.

Experience highlights

Cardiologist with extensive experience across pharma and biotech

Led global medical safety and PV programs, including large outsourced models

Medical Safety Leadership

Signal Evaluation & Risk Management

PV Strategy & Oversight

Vendor & FSP Oversight

Inspection & Audit Readiness

Marcela Fialova, MD

Marcela Fialova, MD

Pharmacovigilance Consultant & Co-Founder, iVigee

Known for

Helping teams build clear, compliant pharmacovigilance systems they can sustain.

Experience highlights

Physician with over 20 years of PV experience across pharma, biotech, and CROs

DIA pharmacovigilance training faculty member

PV System Design & Optimization

PV Governance & Oversight

Vendor & Affiliate Transitions

Audit & Inspection Readiness

Team Enablement

Natalia Kalousova, MD

Natalia Kalousova, MD

Pharmacovigilance Consultant

Known for

Making pharmacovigilance compliance manageable through clarity, structure, and practical guidance.

Experience highlights

Medical doctor with global pharmacovigilance experience

Active member of DIA and ISoP and speaker at international PV conferences

PV Strategy Consulting

Regulatory Intelligence & Compliance

PV System Development & Maintenance

Training & Process Improvement

Vijeet Goel

Vijeet Goel

PV Systems & Technology Consultant

Known for

Helping teams make confident, practical decisions about
pharmacovigilance systems.

Experience highlights

Led large-scale PV system automation during the COVID-19 response

Hands-on experience supporting PV systems across biotech and pharma

PV Systems Strategy

Argus Safety Configuration & Optimization

Veeva Vault Safety Implementation

PV Automation & Digital Transformation

System Simplification & Governance

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FAQ

How do I know which consultant is right for my situation?
Every consultant at iVigee brings deep pharmacovigilance expertise, but their backgrounds and strengths are different. When you reach out, we don’t expect you to self-diagnose. We’ll review what you’re dealing with and help match you with the consultant whose experience best fits your challenge, whether that’s inspection readiness, system design, medical safety decisions, or strategic oversight.
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