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- 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.
- 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.
Pharmacovigilance Co-ordinator - Gravesend, United Kingdom - Qube Recruitment
Description
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:
Qualifications and Experience:
Monday to Friday: Full Time