Hendre Moolman at CK Clinical is looking for a Senior Pharmacovigilance Executive to join a large pharmaceutical company in Buckinghamshire.
As a Senior Pharmacovigilance Executive will work within the Medical Affairs Department and report to the Medical Affairs Manager. The main focus of your role would be to maintain and develop the drug safety processes, delivering a drug safety service for the company’s UK licensed and investigational products. One of the main challenges in this role would be to coordinate multiple tasks with tight deadlines. You will have proven Drug Safety experience with a life science degree.
As a Senior Pharmacovigilance Executive your key responsibilities will be to:
- Perform the activities detailed in the Pharmacovigilance Agreement between Drug Safety Department, Head Office and the UK office
- Your duties will include handling of individual case safety reports (ICSRs), implementing the UK quality system, carrying out literature searches as required
- You will be doing training, compliance reporting, reviewing external agreements relating to drug safety and notifying updates to company core safety information
- Ensure the accurate entry of drug safety case data arising from spontaneous or clinical trial reports
- Liaise with the UK Medical Information personnel (or contractors) and Clinical Research personnel, external healthcare professionals, consumers or the MHRA to obtain available drug safety case information
- Ensure that individual and aggregated safety reports are submitted within the required timelines to the relevant recipients and that a record of reporting compliance is forwarded to the QPPV as detailed in the Pharmacovigilance Agreement
- Keep up-to-date with changes and developments in pharmacovigilance legislation and guidelines and the company’s internal procedures
- Ensure that drug safety processes in the UK meet the current requirements for good pharmacovigilance practice
- Develop and deliver drug safety training programmes relevant to all UK personnel who may be in receipt of drug safety information or perform functions related to drug safety.
- Keep a record of drug safety training carried out by UK personnel and ensure that repeat or updated training is carried out at appropriate intervals
- Maintain electronic and paper filing and archiving system suitable for the storage of source documents relating to drug safety case records
- Foster good relations with Drug Safety personnel at Head Office
Qualifications & Experience:
The successful candidate for this Senior Pharmacovigilance Executive role will have the following qualifications and skills:
- Life science, Healthcare degree, Pharmacist or Nurse
- You must be a natural team player with the personal qualities to relate well to people at all levels.
- Proven relevant industry experience within pharmacovigilance /drug safety
How to apply:
For more information or to apply for this Senior Pharmacovigilance Executive role please contact Hendre Moolman on 01438 870 023 or email email@example.com. Please quote reference CL24169 in all correspondence
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