From Oxford Global Resources we are looking for a Safety / Pharmacovigilance Specialist for an international company of the pharmaceutical industry, placed in Madrid.
It will be a temporary position (1 year) in the beginning, with possibility of continue.
- 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 time lines 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 company products.
The ideal candidate:
- Up to 3 years experience as a safety/pharmacovigiliance technician
- Good knowledge of European law
- Great communications skills
- Pharmaceutical bachelor or related. Master in Pharmaceutical industry is a plus