Pharmacovigilance Officer, Spain - Barcelona, España - Proclinical
Descripción
Proclinical are recruiting for a Pharmacovigilance Officer, Spain to join a consultancy. This role is on a contract basis and is located in Barcelona.Responsibilities:
- Uphold the safety management plan or any other technical document while being accountable for monthly reporting.
- Serve as a safety database administrator for allocated projects.
- You will determine the reportability of ICSRs to pertinent authorities.
- Responsible for expedited and periodic safety proposals to regulatory authorities, such as EVWeb posting/data entry; regulatory authorities' portals, etc.
- Write and track PSURs/PBRERs/PADERs and DSURs with contributions from Safety Physician/ Client.
- Support the tracking of pharmacovigilance linked guidelines and regulations globally for both investigational and marketed products.
- Contribute to the design of PV training programs for clients.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a science field with experience in a pharmacist, biologist role.
- Demonstrable experience within a pharmaceutical/biotech organisation, preferably within pharmacovigilance.
- Knowhow of electronic reporting such as digital certificate; EVWeb posting/data entry, etc.
- Capable of working on various projects simultaneously within a fastpaced, evolving setting under strict deadlines.
- Leadership abilities.
- An organised individual with a high attention to detail and committed to creating high quality outcomes.
- Communication skills both verbally and in writing.
- An influential individual who is creative and works well in a team.
- Computer literacy.
- Fluency in both English and Spanish though any other additional languages would be advantageous.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Pharmacovigilance
CRODelivery
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