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Director of Pharmacovigilance. PharSafer

PharSafer Associates Ltd

Pharmacoviiglance Consultant
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  • Kingston upon Thames, Greater London, United Kingdom
  • English

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Pharmacovigilance and Medical Services Expert

About

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 (www.pharsafer.com) provides further details of our services.

Active Conversations

Experience

Director of Pharmacovigilance & CEO PharSafer Associates Ltd

Head of Pharmacoviiglance, Shire Pharmaceuticals

Education

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

Past Conversations

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Mid-sized CRO desires to expand US PM group to include EU/Global operations. Need expert consultancy and support to build operati...

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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...

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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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