South East England, England
4 months ago
Job title: Pharmacovigilance Officer - UK Affiliate - Southeast
A small but growing pharmaceutical company are seeking a Pharmacovigilance Officer. This is a standalone role with a sole focus on the UK Affiliate. This role will ensure that the business operates in accordance with all relevant Pharmacovigilance standards and to provide critical backup to the Medical Information department.
- Ensures all aspects of the local pharmacovigilance system are maintained to the standard expected by the QPPV and in accordance with company SOPs.
- Keeps the QPPV informed of the national pharmacovigilance requirements.
- Interacts with internal departments such as Quality Assurance and Medical Information where quality complaints and medical information enquiries are associated with safety related information
- Manages (collects, tracks, processes, follows-up and distributes to DSU) ICSRs and other safety information originating from UK.
- Submits relevant ICSRs and SUSARs to the MHRA.
- Monitors drug safety inbox.
- Prepares and maintains Pharmacovigilance Agreements with third-party partners as applicable. Maintains a local register of third-party arrangements for pharmacovigilance.
- A life science degree
- Significant Experience working within pharmacovigilance from a UK affiliate perspective
- A strong understanding of changes pertaining to current pharmacovigilance legislation and confidence in their ability to effectively implement these changes, as necessary
- Experience with Argus, MedDRA, EudraVigilance, XEVMPD
Salary and benefits:
A competitive salary, annual bonus and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org