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Pharmacovigilance Systems Consulting provides pharmacovigilance consultancy services for the pharmaceutical and biopharmaceutical industry worldwide (EU/EEA, USA, Japan), across various therapeutic areas, including orphan drugs, to clients with products either authorised or under development.

ABout

Dr. Eric Caugant M.D.  has over 25 years of experience in Pharmacovigilance, Drug Safety, Risk Management, and more broadly Pharmaceutical Medicine. In 2017, he founded Pharmacovigilance Systems Consulting (PhVSC).

Prior to this Eric held senior positions, in various pharmaceutical and biotech companies, such as Alexion, Bayer Lilly, Wyeth and the French Ministry of Health, gaining an extensive experience in all aspects of pharmacovigilance, including, Pharmacovigilance Systems and processes, Signal Detection, Benefit Risk assessment, Risk Management, Aggregate Periodic Report, training and Quality activities.

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ERIC CAUGANT MD

Founder of Pharmacovigilance Systems Consulting (PhVSC).

About
Expertise

Expertise

Pharmacovigilance Systems Consulting provides pharmacovigilance consultancy services for the pharmaceutical and biopharmaceutical industry worldwide (EU/EEA, USA, Japan), across various therapeutic areas, including orphan drugs, to clients with products either authorised or under development.

Pharmacovigilance consultancy services consist of but are not limited to:

1.

Developing and maintaining Pharmacovigilance Systems and their Quality Systems

2.

Provision of Qualified Person Responsible for Pharmacovigilance (QPPV) and back-up (Deputy), in the EU

3.

Developing risk management systems and strategy

4.

Pharmacovigilance system master file

5.

Pharmacovigilance inspections and audits preparation and management

6.

Process review, gap analysis and improvement,

7.

Periodic Safety Update Report. Benefit-risk analysis

8.

Post-authorisation safety studies

9.

Signal management

10.

Safety communication

11.

Preparing Safety Data Exchange Agreements (SDEA/PVA)

12.

Providing ad hoc medical expertise and Pharmacovigilance trainings

Contact
Contact

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