Essential Duties and Job Functions:
- 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.
- Read and understand relevant procedures, guidance documents and manuals.
- Identifies issues/concerns in a timely and appropriate manner and informs PRP.
- Ensures processes and timelines are followed
- 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.
- Assist the PRP to help the affiliate local pharmacovigilance system is inspection ready.
- Assess and manage safety data and demonstrates general understanding of appropriate labelling documents for the products.
Knowledge, experience and skills:
- Sciences degree and previous experience in PV and / or clinical research (2 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 timelines.
- Very good written and spoken English
If you are looking for an interesting project based in Madrid in one of the most important company don't hesitate and apply attaching your CV!