Pharmacovigilance2024-03-28T16:15:10+00:00
Medical

Pharmacovigilance

JensonR+ actively contributes to the protection of patient safety and public health and our team includes Pharmacovigilance and clinical specialists to promote the safe and effective use of medicines for all. 

Throughout the product life cycle, safety monitoring is an obligation for Marketing Authorisation Holders (MAH) for all licensed medicinal products and our team of specialists can manage all your safety requirements – from the monitoring and safety reporting of clinical trials, triaging medical information calls for commercialised product,  investigating and assessing ICSRs and implementing risk management plans to minimise adverse events.

We strive to provide excellence and strong support to our clients with a full pharmacovigilance service provision. This includes, but is not limited to:

  • Signal Management

  • Case Processing

  • Individual Case Safety Reports (ICSR) Manangement

  • Global Literature Searching and Evaluation

  • Risk Management and Risk Minimisation Measures

  • Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs),

  • PV System Operation via Dedicated Database

  • GVP Audits

  • QPPV/dQPPV and National Contact Person (NCP) Roles

  • Safety and Medical Writing Services

  • PV Strategy and Legislative Guidance

  • PV Physician Access

We can ensure that Marketing Authorisation Holders (MAH) maintain compliance with all relevant Good Clinical Practice (GCP) whatever your needs and your product portfolio, from herbal medicines, specials or generics, we can help you with your safety needs.

The JensonR+ Pharmacovigilance function operates a fully validated safety database for managing and reporting Individual Case Safety Reports (ICSRs), to regulatory agencies. We are able to provide a bespoke PV service, catering for the scale of your operations, designed to meet the global PV environment’s complex and changing needs, for both medicinal products and medical devices.

From smaller clients with a single MAH to global pharma companies with a whole portfolio of products – the JensonR+ team can provide the expert support you need to fulfil your MAH pharmacovigilance obligations and manage your product safety profiles.

Our Team

Specialised and experienced

Our team consists of dedicated, professional and experienced clinical and pharmacovigilance professionals, including our own in-house Qualified Persons for Pharmacovigilance (QPPVs) and deputy QPPVs situated both in the EU and the UK.

Our Pharmacovigilance Services

Click below to learn more about the pharmacovigilance services that we offer.

Recent posts from our Pharmacovigilance team

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Oscar Carter Burns
Oscar Carter-Burns
Pharmacovigilance Team Leader
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