Hendre Moolman at CK Clinical is recruiting for a Drug Safety Associate to join a leading Pharmaceutical company in Surrey on a permanent basis.
Drug Safety Associate Job Description
As Drug Safety Associate you will participate in the delivery of a fully compliant pharmacovigilance system for the UK and ROI. Previous experience in Drug Safety, handling Spontaneous case reporting would be required.
- Conduct all pharmacovigilance activities in compliance with regulatory guidelines and global and local SOPs
- Receipt, processing and follow up of spontaneous adverse event reports
- Review of medical information enquiries and quality complaints for presence of AEs
- Processing of Argus reports received from Central DSP and onward reporting to Competent Authorities where appropriate
- Receipt, review and onward reporting, as appropriate, to central DSP of MHRA ASPR reports
- Reconciliation of medical enquiries, quality complaints and drug safety reports
- Reconciliation of Medical Telephone Enquiry forms across Customer Services and Medical Affairs
- Generation and/or completion of Monthly KPIs
- Input into the continuous improvement of local pharmacovigilance systems including review of existing, and production of new SOPs
- Maintenance of Summary of Pharmacovigilance Systems for NCH-UK
- Generation of local PSURs for submission to MHRA and/or IMB
- Generation of submission forms for global PSURs for submission to MHRA and/or IMB
- Local literature searching
- Local signal detection activities
- Delivery of company wide AE training
- Provide back up for responding to medical information enquiries
- Develop product knowledge across NCH portfolio.
- Deputise for Drug Safety Responsible Person as necessary
- Handling of technical / quality complaints as necessary
- Be nominated “Super User” of CRTS database for medical enquiries, technical (quality) complaints and drug safety reports and be responsible for the CRTS training of new starters within the department
As Drug Safety Associate you will have the following qualifications, skills and experience:
- Life science or nursing graduate
- Experience spontaneous case reporting
- Experience with global safety databases
- Experience using Volume 9A
- Effective communicator both in writing and verbally
- Excellent interpersonal skills
- Able to operate as a flexible team player
How to apply:
For more information, please contact Hendre Moolman on 01438 870 023 or email firstname.lastname@example.org. . Please quote reference CL23522 in all correspondence.