Our Experts for your Pharmacovigilance

Professional – Reliable – Flexible

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Pharmacovigilance

Pharmacovigilance is the continuous and systematic monitoring of the safety of a medicinal product in order to identify, assess and understand its adverse effects and to be able to take appropriate risk minimisation measures as part of Risk Management.

The challenges in Pharmacovigilance are constantly changing and the requirements are constantly increasing. The summary of Good Pharmacovigilance Practices (GVP) can be found here: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/good-pharmacovigilance-practices

In order to always comply with the current legal and scientific requirements, it is good to know that you can rely on competent and flexible partners who have many years of experience in the field of Pharmacovigilance and outsourcing of Pharmacovigilance activities. We support you in setting up an inspection-fit PV system, organise your annual trainings, take on the role of the (D)QPPV, research your literature and take over your Case Management, Audits or other PV topics.

Pharmacovigilance3

We support you in your obligations in the context of human and veterinary Pharmacovigilance, as well as in Clinical Trials.

Our Key Areas

DREHM Pharma has an established Pharmacovigilance System inspected by the Austrian Authorities, which can be used in whole or in part by partners. We are there for you – from complete PV support to the processing of individual projects.

If required, we can take on the following responsibilities for you:

  • Qualified Person responsible for Pharmacovigilance (EU-QPPV)
  • Deputy Qualified Person Responsible for Pharmacovigilance (EU-(D)QPPV)
  • Local Safety Officer (LSO)

You want to develop or update your internal Pharmacovigilance System? We will be happy to support you on the way to your tailor-made system, from the Pharmacovigilance System Master File (PSMF) to the associated SOPs to the necessary agreements (SDEAs – Safety Data Exchange Agreements), or help with specific optimizations.

Our team guarantees timely recording, assessment, processing and medical evaluation of Individual Case Safety Reports (ICSR) and follow-up reports. The control follows the 4-eyes principle, reporting to the authority is possible as quickly as possible thanks to its own database and its own gateway.

We are happy to undertake the time-consuming Literature Search, which must be carried out globally and locally by the Marketing Authorisation Holder of a medicinal product. 

We do research in the relevant trade press, identify case reports and signals and collect relevant publications.

  • Medical Literature Monitoring (MLM)
  • L2A/ L2B
  • PubMed
  • National (Austrian Magazines)

Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) are also a focus of Pharmacovigilance. 

On request, our Aggregate Reports support includes:

  • Preparation and Updating of RMPs
  • PSUR/PBRERs: Creation, Submission and Tracking
  • Risk Minimisation Measures
  • Addendum Clinical Overview (ACOs)
  • Clinical Expert Statement
  • Developmental Safety Update Report (DSUR)

Whether Onboarding Training, specific updates or the mandatory annual PV Training of your employees – we provide your employees with competent and entertaining information and provide you with the relevant documentation.

Pharmacovigilance requirements are constantly changing – we are up to date and keep you up to date.

Team Pharmacovigilance

One of our Areas of Expertise: Audits & Inspections

Audits and Inspections pose particular challenges for most companies. We accept this challenge with pleasure, because we can draw on years of experience and countless inspections, which we have prepared and supervised with and for our customers.

We use our knowledge to optimize your PV System to help you run the audit or inspection smoothly. 

Our PV team is one of the top experts in Austria. We are happy to prepare you for Audits and Inspections or carry out Contract Audits for you.

What are our Qualities?

Professionalism is a matter of course for us at DREHM, as well as finding flexible solutions for all our customers. We are hands-on for you in all tasks, with pleasure – and kindness.

  • Professionalism
  • Reliability
  • Hands-On Mentality
  • Solution-Orientation
  • Flexibility
  • … and Kindness