PgCert Pharmacovigilance

Why choose Herts?

Strong Industry Connections: Delivered in collaboration with the Pharmaceutical Information and Pharmacovigilance Association [PIPA], who contribute to the curriculum and teaching to ensure the up-to-date content is relevant to needs of the industry. Benefit from networking opportunities with our external industry speakers (including Roche and Novartis) and other students working world.

Teaching Excellence: A programme committee of expert speakers provide students with the latest thinking in Pharmacovigilance and access to networking opportunities. Students have the benefit of working with two supervisors for their project dissertation: many of our academic supervisors hold or held senior industry-level roles.

Flexible Blended Learning: This part-time postgraduate programme in Pharmacovigilance is designed for full-time employed professionals within drug safety. This course is flexible blended with online and face-to-face teaching. This programme can take a minimum of 1-2 years to complete, and up until 5 years to work:life:studying balance for students.

International Recognition: The programme has international recognition as an established provider of Pharmacovigilance and Drug Safety education with academic accreditation, focusing on European Union and United Kingdom Pharmacovigilance Regulations and Guidelines, yet providing a rounded global context.

A first or second class Honours degree in Biosciences, Pharmacy or Biological Chemistry
Or a professional qualification accepted as equivalent to the above
Or a qualification in veterinary science, medicine or dentistry
Or a first or second class Honours degree in disciplines that would be judged as equivalent to the above
Plus at least 6 months' experience in full-time Pharmacovigilance work

Find out more about country specific entry requirements.

Applicants not within the categories described above, but who can demonstrate by other qualifications, research publications or appropriate experience that they can succeed on the course will be considered on individual merit.

For international students, proficiency in English as demonstrated by an approved test e.g. IELTS score 6.5, if English is not the first language.

If you do not have the required level of English for entry, our academic English courses can help you to achieve this level.


Institution code	H36
School of study	School of Life and Medical Sciences
Course length	Part Time, 1 Years Part Time, 2 Years
Location	University of Hertfordshire, Hatfield

Employability

Careers

Potential candidates will normally be in either full or part-time employment and are likely to have a spread of responsibilities, mostly in pharmacovigilance and medical information, monitoring safety data in either pre- and post-marketing studies or from spontaneous reports. Students may be graduates and/or experienced personnel and usually will have held positions in drug safety at least 6 months. Some applicants may have doctorates and or may be medically qualified.

Following successful completion of the course the knowledge gained should enable the post-graduates to make a greater contribution to the pharmacovigilance industry.

Feedback from a gradating student about the course "I wanted to express my gratitude for being such an amazing program. It taught me tons and I am so grateful for having the opportunity to meet and collaborate with so many talented, and kind experts! The programme broadens horizons and it is so worth attending!"

Professional Accreditations

This course is accredited by the PIPA (Pharmaceutical Information and Pharmacovigilance Association).

About the course

The PGDip Pharmacovigilance is a course developed by the School of Life and Medical Sciences at the University in collaboration with the Pharmaceutical Information and Pharmacovigilance Association (PIPA). On this course you will study relevant techniques used in pharmacovigilance including the basis of adverse drug reactions, regulations and guidelines (UK, EU and major worldwide regions), handling safety issues including Labelling and Risk Management Systems and processes (both pre and post-marketing).

Why choose this course?

1st for Biosciences in the Postgraduate Taught Experience Survey (PTES, Advance HE, 2023)
Expertise of the staff, who are experienced professionals and have real-world expertise in pharmacovigilance from the pharmaceutical industry and regulatory authorities
Flexibility of study, based on intensive three-day taught courses with independent
Pre and post-coursework activities
Practical research projects based on real-world situations
Opportunities for sharing experiences and networking
There is the flexibility to extend your studies to the MSc in Pharmacovigilance during your studies, in you complete a research project (60 credits)

What will I study?

Taught modules normally consist of approximately 24 hours class contact. In addition, about 120 hours will be needed to complete the pre and post-course activities. The actual amount of time spent will depend upon your existing knowledge and ability. All modules are free-standing.

Satisfactory completion of four modules is compulsory for the PgCert; Compulsory modules for any award include: The Principles of Pharmacovigilance and Pharmacovigilance Regulations and Guidelines, and then choose two additional modules for your interest.

Coursework will contribute significantly to assessment and may comprise some or all of the following: summaries of pre-course reading, written reports of class discussions, essays, performances in seminars, poster presentations, problem solving or data interpretation exercise, short projects and case studies. Unseen written examinations will feature in some courses; they may be used to examine understanding of pre-course reading material. Attendance at the taught component and satisfactory completion of both coursework and examinations (where present), with a minimum mark of 50% in each element, is normally required to pass each module.

Level 7

Module	Credits	Compulsory/optional
Drug Safety in Clinical Trials	15 Credits	Optional
Animal toxicology findings and their relevance to clinical trials. Phases of clinical trials: trial design and analysis (including adaptive design), adverse event reporting and monitoring in clinical trials, protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP), protocol design and safety monitoring aspects of a study, safety biomarkers, safety issues in clinical pharmacology studies, ethics committees; randomisation and the breaking of study codes. Investigator brochures; presentation of safety data from clinical trials; study reports; product licence applications format and organisation of the CTD clinical summaries (in particular the SCS) as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials in determining the safety profile of a new medicine. Statistics. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products (including concepts of IMP, non-IMP). Investigator notifications (IND). Management of urgent safety measures.
Adverse Drug Reactions by Major Body Systems II	15 Credits	Optional
The adverse effect of drugs on the renal, cutaneous, gastrointestinal, musculoskeletal, and endocrine systems. Clinical presentations, case histories and practical examples of adverse drug reactions. Drug interactions: pharmaceutical, pharmacokinetic and pharmacodynamic mechanisms and examples. Drug administration in pregnancy: stages in foetal development and sensitivity to teratogens and other toxic effects on foetal tissue. Use of drugs in nursing mothers: effects on lactation, infant toxicity, relevance of animal toxicology data. Other special groups including: drug use in paediatric patients, the elderly and those with hepatic and renal impairment. Drug overdoses - Poisons Information Centres. Lack of efficacy and Off-label use (GVP VI). Reference to Periodic Safety Update Reports (GVP VII) and Post-authorisation safety studies (GVP VIII).
Management of Pharmacovigilance Data	15 Credits	Optional
Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data (methods used for collection and follow-up). Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, auditing, quality assurance and inspections. PV Databases: Database design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Coding (medical terminology, products and lists of values), PV data values. Electronic Reporting and Safety Data Exchange: Interaction with agencies for seeking information and for electronic interchange, global electronic reporting of individual case safety reports, safety data exchange procedures inter- and intra-companies. Signal Detection: Data Mining and Signal Management (GVP IX), use of adverse experience and prescription data to determine signals. Statistical methods for signal detection.
Principles of Pharmacovigilance	15 Credits	Optional
Historical perspective of pharmacovigilance, international co-operation in pharmacovigilance (GVP XIV), drug safety terminology and definitions of specific adverse events. Principles of safety evaluation during a drug's life-cycle, risk perception and benefit risk assessment (high-level). Differences between small molecules and biological. Causality assessment, reference sources and drugs withdrawn for safety reasons. Sources and optimum composition of spontaneous reports (elements of GVP VI), advantages and limitations of spontaneous report data. Factors affecting spontaneous reporting of ADRs. How the MHRA handles spontaneous data (the Yellow Card System, data collection, signal detection and analysis). MEDWATCH Program in the US, French Regional Pharmacovigilance Centres. Licence partners and safety data exchange agreements (elements of GVP VI). Additional monitoring (GVP X). Descriptive statistics (populations, mean , median, mode, measures of variation, confidence limits).
Adverse Drug Reactions by Major Body Systems I	15 Credits	Optional
Classification of ADRs, pharmaceutical, pharmacokinetic, pharmacodynamic and pharmacogenetic factors leading to ADRs, physiological control systems, clinical chemistry (reference ranges). The adverse effect of drugs on the hepatobiliary, immune, respiratory, cardiovascular, central nervous, haematological. Investigations including monitoring of vital signs, important laboratory and diagnostic tests. Clinical presentations, case histories and practical examples of adverse drug reactions. Criteria for defining ADRs. Exercises to evaluate cases and how these can be determined.
Pharmacoepidemiology	15 Credits	Optional
The development of pharmacoepidemiology as a scientific entity; hypothesis generation and testing, epidemiology of disease, epidemiological study designs, case reports, case series, case control and cohort studies. Post-authorisation surveillance; history and critical analysis and epidemiological implications, non-interventional -v- interventional studies; selection and design examples and critical evaluation. Data selection; quality -v- quantity. A comparative global review of record-linkage databases (strengths and weaknesses) study design considerations. Other sources: Registries and the Cochrane Collaborative database. Performing meta-analysis and handling large data-sets considerations. Integrated benefit risk assessment (GVP VII).
Labelling and Risk Management	15 Credits	Optional
Guidelines/directives on labelling: CIOMS III, IV and V initiatives, ICH guidelines, PV aspects of labelling, Good labelling practice. Pharmacoepidemiology and labelling, Development Core Safety information, Patient Information Leaflets, Data Sheets, Summary of Product Characteristics and Variations (Type I and Type II). Implications of MedDRA. On-going benefit risk analysis (GVP XII), risk minimisation activities, and measurement of their effectiveness, expert views, pre- and post-authorisation data. Safety communication (GVP XV) including communication of risk and public participation in PV (GVP XI). Mass media, crisis management, Risk Management systems (GVP V), Safety data in decision making; management of identified and potential risks. Practical risk management including effective communication. Risk minimisation measures, selection of tools and indicators (GVP XVI).
Pharmacovigilance Regulations and Guidelines	15 Credits	Optional
You will study the following: Interpretation and impact of pharmacovigilance (PV) Regulations/Directives/Guidelines in EU, UK, FDA and other emerging Regulatory Authority requirements. PV System Master File and PV inspections and audits. Communication between pharmaceutical industry, authorities, and healthcare providers. Safety Reporting requirements for medical devices and combination products. Difference in requirements for non-pharmaceuticals. Managing Medication error and falsified medicines report.

Further course information

Course fact sheets
MSc Pharmacovigilance	Download
MSc Pharmacovigilance	Download

Programme specifications
MSc Pharmacovigilance	Download
MSc Pharmacovigilance	Download

Additional information
Sandwich placement or study abroad year	n/a
Applications open to international and EU students	No

Student experience

At the University of Hertfordshire, we want to make sure your time studying with us is as stress-free and rewarding as possible. We offer a range of support services including; student wellbeing, academic support, accommodation and childcare to ensure that you make the most of your time at Herts and can focus on studying and having fun.

Find out about how we support our students

You can also read our student blogs to find out about life at Herts.

Funding and fees
Other financial support

Find out more about other financial support available to UK and EU students

Fees 2024
UK Students
Part time
- £1495 per 15 credits for the 2024/2025 academic year
*Tuition fees are charged annually. The fees quoted above are for the specified year(s) only. Fees may be higher in future years, for both new and continuing students. Please see the University's Fees and Finance Policy (and in particular the section headed "When tuition fees change"), for further information about when and by how much the University may increase its fees for future years.

View detailed information about tuition fees

Living costs / accommodation

The University of Hertfordshire offers a great choice of student accommodation, on campus or nearby in the local area, to suit every student budget.

View detailed information about our accommodation

Read more about additional fees in the course fact sheet
How to apply

2024
Start Date End Date Year Location Link
20/09/2024 31/05/2025 1 UH Hatfield Campus Apply online (Part Time)
15/01/2025 31/07/2025 1 UH Hatfield Campus Apply online (Part Time)
2025
Start Date End Date Year Location Link
20/09/2025 31/05/2026 1 UH Hatfield Campus Apply online (Part Time)
15/01/2026 31/07/2026 1 UH Hatfield Campus Apply online (Part Time)

Start Date	End Date	Year	Location	Link
20/09/2024	31/05/2025	1	UH Hatfield Campus	Apply online (Part Time)
15/01/2025	31/07/2025	1	UH Hatfield Campus	Apply online (Part Time)

Start Date	End Date	Year	Location	Link
20/09/2025	31/05/2026	1	UH Hatfield Campus	Apply online (Part Time)
15/01/2026	31/07/2026	1	UH Hatfield Campus	Apply online (Part Time)

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PgCert Pharmacovigilance

Why choose Herts?

Careers

Professional Accreditations

About the course

Why choose this course?

What will I study?

Further course information

Student experience

Other financial support

Fees 2024

UK Students

Part time

Living costs / accommodation

2024

2025