Qualification Course: Head of Pharmacovigilance

The qualification programme provides you with sound, practice-oriented knowledge for your role as Head of Pharmacovigilance.
You will deepen your understanding of the legal responsibilities involved in leading a PV system, quality-assured management using appropriate KPIs, and strategic and operational issues relevant to experienced PV professionals. You may select the elective module according to your individual area of interest.

The EU Qualified Person for Pharmacovigilance (EU QPPV)
Legal foundations, core responsibilities, and practical application

2 days | Online Seminar | 2 fixed dates per year

This intensive course provides a comprehensive introduction to the regulatory, organisational and practical requirements for EU QPPVs. You will gain a clear understanding of your role and responsibilities and learn how to manage your tasks confidently and systematically in day-to-day business.

Topics:

• Legal framework, liability, and legal protection
• Regulatory requirements for day-to-day practice
• Maintaining oversight of your pharmacovigilance system
• Specific tasks, responsibilities, and possible delegations
• Ensuring compliance

Pharmacovigilance Key Performance Indicators
KPIs for a robust PV system

1 day | Online Seminar | 1 fixed date per year

This compact online course provides you with sound, practice-oriented knowledge for selecting, defining, monitoring and reporting Key Performance Indicators in pharmacovigilance. You will learn how to use mandatory and optional, quantitative and qualitative KPIs to strengthen the quality, compliance and inspection readiness of your PV system.

Topics:

• Regulatory requirements and best practices
• A step-by-step approach to defining PV KPIs
• Quantitative and qualitative KPIs
• Tracking KPIs
• Presenting KPIs and building dashboards for audit readiness
• Dos and don'ts: The most common mistakes when defining KPIs

Master Class: Local QPPV, EU QPPV, and Head of PV
The advanced seminar for experienced pharmacovigilance professionals

1 day | Online Seminar | 1 fixed date per year

This Master Class addresses key strategic and operational questions that experienced pharmacovigilance professionals face in their daily work. You will deepen your knowledge of PV SOPs, the PSMF, complaints, recalls and CAPA, and receive practical input for effective stakeholder and deviation management.

Topics:

• PV SOPs: Which processes require them, and when are they useful?
• PSMF: One document for clarity
• Handling complaints and product recalls
• Stakeholder management
• Deviation management and CAPA

Your choice of a one-day seminar
Which topic is most relevant to your professional role?

1 day | Online seminar | Regular dates throughout the year | German and / or English

Depending on your company’s size and organisational structure, different pharmacovigilance topics may be particularly relevant to you. If you outsource numerous activities or roles, take a look at our seminars on "Outsourcing and Vendor Management in Pharmacovigilance". Are you also responsible for drug safety in clinical trials and involved in their planning? In this case, our seminar on "Drug Safety in Clinical Trials" may be of particular interest to you. Discover our full portfolio on the Pharmacovigilance Training page. Choose a one-day seminar that suits your needs and let us know which topic you are interested in.

Some possible seminars:

• Outsourcing and Vendor Management in Pharmacovigilance
• The Pharmacovigilance System Master File (PSMF) in a Global Environment
• RMP and PSUR in life-cycle management: An art, not a miracle
• Drug Safety in Clinical Trials

You will take part in four live training sessions (modules) within 24 months. These take place on fixed dates. We plan our events approximately six months in advance. You can select any dates that have already been published when booking. If you would prefer to attend a later seminar date, please select the option "Please keep me informed about the upcoming dates by email". The three compulsory modules provide you with a comprehensive overview of the responsibilities and essential tasks of a Head of Pharmacovigilance. An additional elective module allows you to choose a topic according to your personal interests.

Our compulsory modules are offered at least twice a year, and the elective modules at least once a year. If you are unable to attend on a specific date, or if your preferred seminar is not yet available online, this is not a problem. Simply book the programme, and we will arrange the seminar dates with you individually.
If you have any questions or would like personal support in selecting or booking your modules, please feel free to contact me directly at n.wolff@forum-institut.de or by telephone at 06221 500-696.

• Your employer invests in high-quality and well-prepared knowledge transfer, ensuring a solid foundation of expertise within the company.
• You are up to date and contribute current know-how to the organisation.
• Benefit from the carefully selected seminar package and approve four training sessions in one process.
• Your employer saves up to 25% compared with individual seminar bookings.