• Pharmacovigilance & QP services
  • Pharmacovigilance

Monitoring of drug safety

Over the last few decades, pharmacovigilance has become more and more important due to the increasing consumption of medicines.

Range of pharmacovigilance services

Although a medicinal product is only authorised after extensive clinical trials, not all possible adverse reactions are known before marketing authorisation, especially rare or late-onset side efects. It is therefore essential to constantly monitor drug safety once a medicinal product has been launched on the market.

We are an experienced and interdisciplinary team. Based on good pharmacovigilance practice (GVP) recommendations we provide comprehensive and individual support for all pharmacovigilance matters.

Pharmacovigilance tasks

We undertake individual pharmacovigilance activities:

  1. Literature research
  2. Evaluation and timely submission of adverse-event reports (incl. follow-up)
  3. Maintenance of your company-specific-drug-reaction database
  4. Periodic reports (PSURs/PBRERs) and addendum to the clinical overview
  5. Risk-management plans (RMPs)
  6. Signal management and continuous safety evaluation
  7. Extended EudraVigilance product report message/medicinal product dictionary (XEVPRM/XEVMPD)

Pharmacovigilance systems

Set-up and optimisation of pharmacovigilance systems:

  1. Consulting and support during set-up, the further development and review of your pharmacovigilance systems
  2. Creation and maintenance of your pharmacovigilance system master file (PSMF)
  3. Creation, review and maintenance of SOPs
  4. Training staff and sales force
  5. Conducting system audits (self-inspections)
  6. Preparation and follow-up of inspections
  7. Taking on the functions of the responsible person (EU-QPPV, graduated plan officer)
  8. Consulting on EudraVigilance
  9. Undertaking pharmacovigilance in clinical trials

Information on privacy for pharmacovigilance

Information on how we process your personal data according to Article 13 of the GDPR can be found in the information centre under data protection.

Contact us. We’re happy to help!

Karlheinz Gutzler

Phone: +49 7272 7767-2525

Silvia Öttl
Sales Manager

Phone: +49 7272 7767-2561


How is pharmacovigilance defined?

The term "pharmacovigilance" is derived from the Greek word "pharmakon" (medicine) and the Latin word "vigilans" (vigilant). Pharmacovigilance is the continuous and systematic monitoring and control of the safety of a medicinal product after its launch in order to detect, evaluate and understand adverse effects. It also allows appropriate action to be taken to minimise risk. The continuous monitoring of drug safety aims to ensure the health and well-being of patients.

What does GVP mean?

The Good Pharmacovigilance Practice (GVP) guideline is a set of modules covering all aspects of pharmacovigilance. It defines how the safety of medicines should be monitored and controlled after they have been authorised. The GVP guidelines aim to ensure that pharmacovigilance is carried out consistently and effectively in the European Union (EU). They cover aspects such as adverse reaction reporting and analysis, risk management and quality assurance. The European Medicines Agency (EMA), which works closely with the national regulatory authorities of the EU Member States, is responsible for implementing and monitoring the guidelines.

What is the role of a graduated plan officer or the QPPV?

The graduated plan officer, and, at European level, the QPPV (Qualified Person Responsible for Pharmacovigilance) play a central role in pharmacovigilance.

The QPPV is responsible for the safety of a company's medicinal products authorised in the European Union (EU) and is the main contact person for the competent authorities. The graduated plan officer is the main contact person for the authorities in Germany.

The responsibilities of the graduated plan officer are defined in the Medicinal Products Act (AMG) and the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV) and include:

  • Monitoring the safety of all medicinal products in a company.
  • The graduated plan officer must set up and maintain a pharmacovigilance system and process reports on drug risks (PV system).
  • Ensuring that all company personnel receive appropriate and regular training,
  • Monitoring and reporting of adverse drug reactions (ADRs) and other safety-related information.
  • Systematically documentation of all complaints and information of the authorities of any defect that could lead to a recall or unusual restriction of distribution.
  • Carrying out risk assessments and, if necessary, recommending measures to minimise risks in the event of new safety data or events.
  • Contact person for communication with the relevant authorities.
  • Ensuring compliance

What is a risk management plan (EU-RMP)?

A risk management plan (RMP) must be submitted at the time of application for the marketing authorisation of a medicinal product. The risk management plan is therefore an integral part of the marketing authorisation. The requirements for an RMP are laid down in the GVP module V (risk management systems). Depending on the type of marketing authorisation application (e.g. for a generic medicinal product or a medicinal product with a new active substance), the requirements may vary considerably.  As not all facts are known at the time of marketing authorisation for a new active substance, the RMP must describe both known and suspected potential risks and define appropriate risk mitigation measures.

What is meant by XEVMPD and XEVPRM?

The abbreviation "XEVMPD" stands for "eXtended EudraVigilance Medicinal Product Dictionary" and refers to a database in which all medicinal products authorised in the European Union (EU) and the European Economic Area (EEA) must be registered.

"XEVPRM" stands for "eXtended EudraVigilance Product Report Message". This is a specific data format used by marketing authorisation holders to submit information on medicinal products to the XEVMPD database. The EMA informs the MAH or QPPV about important safety events for certain medicines, so it is important that all marketing authorisations are correctly recorded in the XEVMPD database.

What are adverse reaction reports?

Adverse reaction reports (ADRs) are reports of harmful and unintended reactions to a medicinal product. ADRs can be reported by patients or healthcare professionals. The processing of adverse reaction reports is essential for monitoring the safety of medicinnal prducts. They help to identify potential risks, take actions if necessary, and update information for healthcare professionals and instructions for use if new risks are identified. Patients and healthcare professionals are encouraged to report adverse reactions. Many countries have specific reporting forms or online platforms through which such reactions can be reported. HWI's pharmacovigilance department processes these adverse reaction reports for its clients and carries out the necessary submissions to the relevant regulatory authorities.

Does a marketing authorisation holder always have to appoint and notify a graduated plan officer, even if the marketing authorisation holder does not place the medicinal product on the market in Germany, but, for example, a co-marketer does?

Yes. If a marketing authorisation holder (even if not based in Germany) supplies a medicinal product to a co-distributor, it places the medicinal product on the market. The marketing authorisation holder therefore remains responsible for the medicinal product and must appoint a graduated plan officer.


Monday - Friday

+49 7272 7767-0