ObjectivesThe 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.
Entry requirementsEntry requirements -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
Academic titlePharmacovigilance MSc, PgD, PgC
Course descriptionThe aim of this MSc is to provide a postgraduate education in pharmacovigilance, including relevant techniques, the basis of adverse drug reactions, regulations and guidelines, 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.
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. 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. You will be able to obtain any one of the awards in a minimum of two years; however registration for up to five years is permissible within the programme.
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.
Teaching methods
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 required for the PgDip and MSc. 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.
Course content
Year 1 - full details
Core modules
-Adverse Drug Reactions by Major Body Systems
-Labelling and Risk Management
-Pharmacoepidemiology
-Project - Pharmacovigilance