Hendre Moolman at CK Clinical is recruiting for a Pharmacovigilance Consultant to join a company in the pharmaceutical industry in a contract role in the South East.
As Pharmacovigilance Consultant you will be responsible for the documentation and processing of adverse drug reactions reports.
Further responsibilities of this Pharmacovigilance Consultant position will include:
- Expedited reporting of adverse drug reactions to EEA competent authorities, including reporting via EudraVigilance
- Routine searches and evaluation of published medical and scientific literature for identification of individual case safety reports (ICSRs) and drug safety data
- Preparing PSURs
- Preparing and maintaining Risk Management Plans (RMPs) for clients
- Undertaking signal management activities
- Liaising with clients regarding their requirements for handling of adverse reactions, including registration with EudraVigilance
As Pharmacovigilance Consultant you will have the following qualifications, skills and experience:
- A degree in life sciences or a background in nursing
- A proven pharmacovigilance experience
- An excellent understanding of medical terminology
- Experience in the interpretation of medical and scientific literatures
- Experience in searching medical literature databases (e.g. PubMed)
- Be computer literate (primarily Word, Excel, PowerPoint)
- Have a basic understanding of Quality Management Systems and working with Standard Operating Procedures (SOPs)
- Excellent written and verbal communication skills
- An excellent interpersonal skills with the ability to work with a number of different clients according to their various requirements
- A good knowledge of the rules governing medicinal products in the EEA, including the legislation governing the pharmacovigilance requirements
- Be well organised, efficient and self-motivated with the ability to work to tight deadlines within a small company environment
Desirable but not essential:
- Experience or knowledge of the preparation and maintenance of Pharmacovigilance System Master Files (PSMFs)
- Experience in the submission and maintenance of products in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
- Experience in the participation of pharmacovigilance inspections
As Pharmacovigilance Consultant you will be joining a global pharmaceutical company based in the South East.
How to apply
For more information or to apply for this Pharmacovigilance Consultant position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org. Please quote reference CL25907 in all correspondence.