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Director of Pharmacovigilance. PharSafer

PharSafer Associates Ltd

Pharmacoviiglance Consultant a Conversation

Areas of Expertise

  • United Kingdom
  • English


25 years Pharmacovigilance and Medical Services experience and started PharSafer 12 years ago as a specialist Drug Safety and Medical Services CRO.

Operating a global full service to clients we provide both post-marketing and clinical safety activities from case processing to safety reviews to PSUR/PBRER/DSUR/Periodic submissions and RMPs/REMs, contract EU QP PV and PV Training.

We have taken part in many Inspections from FDA; HPB and numerous EMA inspections helping over 100 Companies pre-; post; and during the Inspections. We have helped extensively in CAPA resolution.

Our clients range from Innovator; generic; OTC; Biologic; Vaccine; Advanced Therapy; Biosimilars; Medical Devices and Cosmetics - truly an eclectic array.

Our clients have global products - generic and innovator - as well as Orphan designated products.

We operate globally reporting in over 100 countries and our website ( provides further details of our services.

Active Conversations With Clients

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Dear Sirs/Madams, We are looking for training in xEVMPD. I have attended the EMA training and passed the evaluation two years ago...


Director of Pharmacovigilance & CEO PharSafer Associates Ltd

Head of Pharmacoviiglance, Shire Pharmaceuticals


BSc (Hons) Biochemistry & Pharmacology
PhD Drug metabolism & pharmacokinetics

Past Conversations With Clients

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I am a consultant in Patient safety & Pharmacovigilance. I looking for a QPPV on contract (consultant) to support Pharmacovigilanc...

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i would like to know about the templates used in writing IQ,OQ/PQs and the SOPs created. please explain with an example. being a...

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