Hendre Moolman at CK Clinical is recruiting for a Pharmacovigilance Manager to join a company in the pharmaceutical industry in a permanent role in the South East.
As Pharmacovigilance Manager you will be responsible for the documentation and processing of adverse drug reactions reports.
Further responsibilities of this Pharmacovigilance Manager position will include:
- The documentation and processing of reports of adverse drug reactions.
- 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
- Preparation of PSURs
- Preparation and maintenance of 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 Manager you will have the following qualifications, skills and experience:
- Solid pharmacovigilance experience
- Degree in life sciences discipline / background in nursing
- Excellent understanding of medical terminology.
- Experience in the interpretation of medical and scientific literature.
- Experience in searching medical literature databases (e.g. PubMed)
- Computer literate (primarily Word, Excel, Power Point)
- Basic understanding of Quality Management Systems and working with Standard Operating Procedures (SOPs)
- Excellent written and verbal communication skills.
- Excellent interpersonal skills with the ability to work with a number of different clients according to their various
- Good knowledge of the rules governing medicinal products in the EEA, including the legislation governing the pharmacovigilance requirements.
- Well organised, efficient and self-motivated with the ability to work to tight deadlines within a small company environment.
- Car driver essential due to location
Desirable but not essential:
- Experience/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 Manager 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 Manager position please contact Hendre Moolman on +44 (0)1438 842 970 or email email@example.com. Please quote reference CL25912 in all correspondence.