MSc Pharmacovigilance

Why choose Herts?

Industry Affiliation: 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.

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: an academic supervisor and a work-based supervisor to advise them. Many of our academic supervisors hold or held senior industry-level roles.

Strong Industry Connections: Benefit from networking opportunities with our external industry speakers (including Roche and Novartis), industry research supervisors and other students working worldwide.

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.

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, 5 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. They will be graduates and/or experienced personnel and usually will have held positions in drug safety for one to several years. Some applicants may have doctorates and 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.

Professional Accreditations

PIPA (Pharmaceutical Information and Pharmacovigilance Association)

About the course

The aim of this MSc is to provide a postgraduate education in pharmacovigilance, including relevant techniques, the basis of adverse drug reactions, regulations and guidelines (UK, EU and major worldwide regions), handling safety issues including labelling and risk management and systems and processes. Teaching consists of lectures and workshop activities in small groups and takes into account real world situations. There are opportunities for sharing experiences and networking which contributes to the development of your knowledge and understanding of pharmacovigilance issues.

Flexible programme

This is a flexible programme designed to meet the needs of those in either full or part-time employment who are likely to have a spread of responsibilities. Students are able to complete the MSc course in under three years if able to attend all modules at the earliest opportunity. Alternatively, they can take up to five years, progressing at a slower pace.

Participants will normally be graduates and/or experienced personnel and usually will need to have held positions in drug safety for one to several years. The programme is run as a series of intensive short courses supplemented with substantial pre and post-course reading and set coursework. In addition, if you are studying for an MSc, you will undertake a research project that is normally carried out at your workplace but may be done at the University, or an institution with appropriate experience of pharmacovigilance or adverse drug reactions.

The programme has attracted students from European Union countries, Norway, Switzerland, Japan and the USA and its success has led to the organisation of an annual Pharmacovigilance Update day for those who have completed their studies.

Recruitment will take place at the beginning of each taught module and the programme offers the awards of a PgC, PgD or MSc. Students are typically able to obtain any one of the awards in a minimum of two years; however you have a maximum registration of up to five years in order to complete the course. This course has the option of being a diploma if you do not feel you can commit to the full MSc programme.

Why choose this course?

1st for Biosciences in the Postgraduate Taught Experience Survey (PTES, Advance HE, 2023).
The MSc/PgD/PgC in Pharmacovigilance is a programme developed by the School of Life and Medical Sciences Sciences in collaboration with the Pharmaceutical Information and Pharmacovigilance Association (PIPA).
The programme includes eight taught modules, and for the MSc award, a research project.
It is taught mainly through teams of staff drawn from the professions appropriate to pharmacovigilance. This is a major feature of the programme, the majority of staff delivering the courses will be acknowledged experts.
The aim is to provide a postgraduate education in pharmacovigilance, including relevant techniques, the basis of adverse drug reactions, regulations and guidelines, handling safety issues and the role of systems and processes.
Students will attend a three-day block teaching, per module which is delivered online and in-person simultaneously, during a working day in United Kingdom time-zone.
In addition to offering this course, The University of Hertfordshire is also part of the Eu2P European Programme in Pharmacovigilance and Pharmacoepidemiology, an online pan European e-learning/e-teaching MSc course.

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; all eight modules are compulsory for the PgDip and MSc. Compulsory modules for any award include: The Principles of Pharmacovigilance and Pharmacovigilance Regulations and Guidelines

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
Pharmacovigilance Regulations and Guidelines	15 Credits	Optional
Students will study a range of content including the topics detailed below. Emphasis is placed on the interpretation and impact of pharmacovigilance regulations on the pharmaceutical industry both pre- and post-authorisation. EU Regulations and Directives on Pharmacovigilance (PV), PV Guidelines, CIOMS (I, II, III, IV and V) and ICH guidelines. EU Medical Device Regulation. Clinical trial regulation and license applications. The MHRA, Medicines Acts Information Letters (MAILs). Association of the British Pharmaceutical Industry (ABPI) Code of Practice (relevant parts). FDA Regulations: expedited and periodic reporting, investigational new drugs (IND), new drug applications (NDA). New Post Marketing Safety Reporting (PMSR) requirements for combination products (81 FR 92603). Other countries PV regulations and guidelines as appropriate (e.g. Japanese, China) and emerging regional models (e.g. Africa). Communication between authorities, data sheets and labelling updates. PILs and patient information packs; safety information requirements. Difference in requirements for small molecules, biologics, vaccines and medical devices. Summary of product characteristics. PV System Master File (PSMF) (GVP II). PV inspections (GVP III) and audits (GVP IV). GDPR and its relevance to PV. AI & machine learning in PV; expectations, validation, assessment in PV inspections and potential signal management use. Guidance from FDA CDRH division in 2019 and emerging guidance from MHRA. The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day block teaching.
Drug Safety in Clinical Trials	15 Credits	Optional
Students will study a range of content including the topics detailed below. Animal toxicology findings and relevance to clinical trials, phases of clinical trials, adverse event reporting and safety monitoring in clinical trials. Protocol development and Case Report Form (CRF) design, Good Clinical Practice (GCP) and Ethic committees. Randomisation and the breaking of study codes, Investigator brochures; presentation of safety data from clinical trials and study reports. Revised CTFG guidelines and the RSI. Product license applications format and organisation of the CTD clinical summaries as per ICH M4E; NDAs, SPC expert reports, large scale end-point studies and safety monitoring boards. Limitations of clinical trials. DSURs (ICH E2F) including non-clinical information. Clinical trials involving vaccines and biologics. Drug use in paediatrics (PIP). Guidance on 2011/C 172/01 (CT-3) including concepts of IMP, non-IMP. Investigator notifications (IND) and the management of urgent safety measures. Combination products; handling IMP's with a device constituent and use of technologies to support safety activities in clinical trials e.g., wearables. Clinical trials in rare diseases and oncology; available evidence and safety surveillance. Post authorisation efficacy and safety studies (PAES, PASS) (GVP VIII) and statistics will also be covered. The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course.
Adverse Drug Reactions by Major Body Systems II	15 Credits	Optional
Students will study a range of content including the topics detailed below. 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. Varying the surveillance approach to identifying events via symptoms. 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). The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course.
Management and Reporting of Pharmacovigilance Data	15 Credits	Optional
Students will study a range of content including the topics detailed below. Good pharmacovigilance practices (GVP I): Pharmacovigilance (PV) systems and their quality systems. Company processes and procedures for handling data. Information Systems and Compliance: Use of SOPs, working practices and guidelines in data management, data auditing, quality assurance, inspections and considerations for introducing process automation. PV data sources; relative value and their management (e.g. spontaneous, literature, interventional clinical trials, NIS, patient support programs, market access programs, social media, digital channels. Drivers for re-opening in ICH E2D in the digital era. PV Databases design (vendor and bespoke systems), customisation, implementation and validation (relevant regulations including data privacy), maintenance of company systems and upgrades. Potential to apply emerging automation technologies (e.g. AI, machine learning, natural language processing) to augment the management, analysis and reporting of PV data. Coding, PV data values. Electronic Reporting and Safety Data Exchange. Signal Detection: Data Mining and Signal Management (GVP IX), good practices for signal management (e.g. IMI-PROTECT guidances) and emerging predictive safety modelling approaches in clinical trials. Utilisation of EVDAS, Vigibase & FAERs; GVP IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspect adverse drug reaction. The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course.
Project, Pharmacovigilance	60 Credits	Optional
The Project provides the opportunity for extended, in-depth study on a selected aspect from within the scope of the programme and will cover the breadth of the discipline and student interest. In choosing their projects students will be encouraged to broaden or extend their experience beyond that in previous certified learning. Projects are non-laboratory based and are usually conducted at the student's place of work. All students have a University supervisor allocated to them, in addition to a workplace supervisor. Both supervisors will guide the student in their choice of project work, literature search, research methods, data evaluation and report writing. Tutorials with supervisors will include discussion on aims, objectives current theories, research design, data collection and analysis, and the structure of the report.
Principles of Pharmacovigilance	15 Credits	Optional
Students will study a range of content including the topics detailed below. Historical perspective of pharmacovigilance, international co-operation in pharmacovigilance, drug safety terminology and definitions. Pharmacovigilance systems and their quality management systems (GVP I). Principles of safety evaluation during a drug's lifecycle, risk perception and benefit risk assessment (high-level). Examples of drugs withdrawn for safety reasons. Differences between medicinal products e.g., small molecules, biological, combination products and medical devices. Causality assessment, reference sources of safety information. 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, and other regional pharmacovigilance centres. Licence partners and safety data exchange agreements (elements of GVP VI). Additional monitoring overview (GVP X). Descriptive statistics used in drug safety surveillance. Overview of general types of technologies/systems/applications in use to enable pharmacovigilance activities. The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course.
Adverse Drug Reactions by Major Body Systems I	15 Credits	Optional
Students will study a range of content including the topics detailed below: The classification of ADRs, pharmaceutical, pharmacokinetic, pharmacodynamic and pharmacogenetic factors leading to ADRs, clinical chemistry (reference ranges). Body systems/organ classes. The adverse effect of drugs on the hepatobiliary, immune, respiratory, cardiovascular, central nervous, haematological; clinical presentations, case histories and practical examples of adverse drug reactions. Investigations including monitoring of vital signs, important laboratory and diagnostic tests. Clinical presentations, case histories and practical examples of adverse drug reactions. Class effects e.g., PD1 class effects. Criteria for defining ADRs. Exercises to evaluate cases and how these can be determined. Examples of causality models / criteria, such as Edwards, and their application. The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course.
Pharmacoepidemiology	15 Credits	Optional
Students will study a range of content including the topics detailed below: 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. The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course.
Risk Management and Labelling	15 Credits	Optional
Students will study a range of content including the topics detailed below: Principles of Risk Management and how risks are classified in the EU. Review of global requirement for risk management and managing these requirements. On-going benefit risk assessment, expert views, pre- and post-authorisation data. Practical risk management (GVP V), including effective communication; management of identified and potential risks. Pharmacovigilance Activities (routine & additional). Risk minimisation measures (routine & additional), selection of tools and indicators (GVP XVI). Safety communication (GVP XV) including communication of risk and public participation in PV (GVP XI). Communication of risk via digital channels/technologies. Supporting stakeholders in putting risk into context, crisis management (e.g. product withdrawal, USR, etc). Guidelines/directives on labelling: CIOMS III, IV and V initiatives, ICH guidelines, 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 & applying frequency in labels. Handling region/country variations. Labelling technology and how label is used for assessment (Case, signal etc). The module will be delivered in three parts; students will be provided with pre-module reading to introduce them to the topics of the module. This will be followed by attendance at lectures and workshops during an intensive 3-day residential course in Hatfield. The final part will be a module assignment to be completed after the 3-day course.

Key staff

Dr Chris Benham
Admissions Tutor
Find out more about Dr Chris Benham

Ms Marika Vousden
Admissions Tutor
Find out more about Ms Marika Vousden

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	Yes

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.

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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
- £790 per 15 credits for Project module for the 2024/2025 academic year
EU Students
Part time
- £1495 per 15 credits for the 2024/2025 academic year
- £790 per 15 credits for Project module for the 2024/2025 academic year
International Students
Part time
- £1495 per 15 credits for the 2024/2025 academic year
- £790 per 15 credits for Project module 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.

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

International/EU applicants without pre-settled status in the UK

Apply through our international/EU application portal

Home and EU applicants with pre-settled/settled status in the UK

2024
Start Date End Date Year Location Link
14/09/2024 20/05/2025 1 UH Hatfield Campus Apply online (Part Time)
19/01/2025 15/01/2026 1 UH Hatfield Campus Apply online (Part Time)
2025
Start Date End Date Year Location Link
14/09/2025 20/05/2026 1 UH Hatfield Campus Apply online (Part Time)
19/01/2026 15/01/2027 1 UH Hatfield Campus Apply online (Part Time)

Start Date	End Date	Year	Location	Link
14/09/2024	20/05/2025	1	UH Hatfield Campus	Apply online (Part Time)
19/01/2025	15/01/2026	1	UH Hatfield Campus	Apply online (Part Time)

Start Date	End Date	Year	Location	Link
14/09/2025	20/05/2026	1	UH Hatfield Campus	Apply online (Part Time)
19/01/2026	15/01/2027	1	UH Hatfield Campus	Apply online (Part Time)

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MSc Pharmacovigilance

Why choose Herts?

Careers

Professional Accreditations

About the course

Flexible programme

Why choose this course?

What will I study?

Key staff

Further course information

Student experience

Other financial support

Fees 2024

UK Students

Part time

EU Students

Part time

International Students

Part time

Living costs / accommodation

International/EU applicants without pre-settled status in the UK

Home and EU applicants with pre-settled/settled status in the UK

2024

2025