Oxford Global Resources ETT is looking for a TOP BIOPHARMA, which is focused on the discovery, development, and commercialization of innovative medicines, a Pharmacovigilance Manager who will join its team in Madrid being offered flexible conditions office-based and home-based. This is an interim 12 months project length.
AS a PV Manager your role means to be responsible for the quality and compliance of all PV deliverable and be involved in training, business development, audits/inspections, client relationship management and line management.
- Management of individual case safety reports and reporting to local Health Authorities
- Review of local literature and identification of applicable safety data
- Interact with other PVE functional areas to process adverse events efficiently and reliably.
- Interact with other local functions areas to process safety information and adverse events efficiently and reliably.
- Overseeing the local PVE Quality Management System. Assist in the maintenance of the local pharmacovigilance system in accordance with global and local pharmacovigilance SOPs and local requirements in order to ensure regulatory compliance.
- Able to analyze data, identify trends and consistently recognizes anomalous and inconsistent data and seeks appropriate input for corrective action or retraining.
- Assist the PRP to help the affiliate local pharmacovigilance system is inspection ready.
- Provide drug safety training to internal groups or external groups
- Sciences degree and previous experience in PV and / or clinical research (4 years)
- Excellent interpersonal and communication skills, both written and oral
- Demonstrates initiative, teamwork and accountability
- Demonstrate ability to work both independently and in collaboration with others
- A quality driven individual with strong attention to detail and accuracy is required
- Strong organizational skills, and ability to adapt to change
- Ability to manage own workload, prioritize, plan and organize assignments and work under strict time lines.
- Very good written and spoken English
- Home-working flexibility
- Ticket restaurant
- Medical insurance
- English classes