Publikováno v: Ostatní v Jihovýchodní Anglie | Nejnovější změněné: |
Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit a Pharmacovigilance Co-ordinator.
Job Description:
* Develop and approve artwork components and patient information (SPC, PIL, cartons and labelling) and associated mock-ups.
* Liaise with project managers for implementation of updated product information.
* Co-ordinate with external pharmacovigilance contractors for submission of safety variations and PSUSA variations
* Co-ordinate with pharmacovigilance contractors for updating and approval of risk minimisation material.
* Responsible for maintaining and distribution of Risk minimisation material through external contractors.
* Experience in uploading the product information to databases like EMC.
* Review and provide sales data for PSUR reporting.
* Conduct regular meetings with external pharmacovigilance contactors for the ongoing pharmacovigilance activities.
* Responsible for ensuring all the relevant contracts are in place for pharmacovigilance activities carried out via external parties in UK & EU.
* Responsible for completing detailed monthly PV Summaries.
Qualifications and Experience:
* Educated to degree level in science or equivalent experience.
* Minimum 3 years of experience in the Regulatory Affairs & Pharmacovigilance
* Proficiency in the use of MS Office suite (Excel, PowerPoint)
* Ability to take initiative and work with different departments as a team player within the organisation.
Monday to Friday: Full Time