Pharmacovigilance Specialist - W.London
Our leading client is looking for Pharmacovigilance Specialist to join their expanding company.
This is a full-time and office-based role.
They are looking for both a Contract and a Permanent candidate.
The Pharmacovigilance Specialist will be responsible for the day-to-day management of all pharmacovigilance activities, ensuring compliance with PV processes/regulations, corporate policies/procedures and monitoring of adverse events. The Pharmacovigilance Specialist will report to the Pharmacovigilance Lead.
Responsibilities of the Pharmacovigilance Specialist:
- Day-to-day adverse experience case management including case intake and follow-up activities, the review of local and health authority submissions of cases
- Responsible for aggregate safety report submissions
- Reconciliation of adverse events reports received from other internal company operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
- File, store and archive safety-related data
- Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection
- Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors/vendors/business partners
- Bachelor’s Degree (or equivalent) in a Life Science, Medical Science or relevant discipline
- Previous experience working within the pharmaceutical/clinical research industry
- Sound understanding of pharmacovigilance regulations in the UK
- Strong project management skills with the ability to prioritize assignments/manage time
- Good Documentation Practices and awareness of Good Clinical Practice concepts
- Compliance mindset/focused, high level of accuracy and quality in work
- Familiarity with the use of a safety databases and demonstrated ability to learn new computer interface systems
- Strong collaboration skills with the ability to work across different departments
- Proven ability to work independently with minimal supervision
- Excellent communication skills both verbally and in writing