Drug Safety Specialist job in Hatfield, Hertfordshire

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Discipline: Drug Safety / Product Safety

Job type: Permanent

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

A leading pharmaceutical client is searching for a Drug Safety Specialist to join their team in Hatfield. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe.

To process Individual Case Safety Reports (ICSRs) received at EELPV to a high quality and ensure compliant case processing in the EMEA region

Job Responsibilties:

To ensure that all ICSRs relating to EMEA products are processed by EEL PV, from receipt to submission, in accordance with timelines and standards specified in internal controlled documents
To ensure that ICSRs are submitted to regulatory agencies and distributed to company affiliate offices and partners in accordance with regulatory and company requirements and timelines.
To ensure accurate input of source data onto the global safety database (ARISg) and perform QC check of ICSRs
To undertake and participate in training relating to ICSR processing, quality and compliance
To perform PV activities relating to ICSR management as described in the ICSR Rota
To assist in maintaining appropriate ICSR documentation which reflects current ICSR processes
To support the EEL PV Safety Evaluation Team in the preparation and quality control of ICSR listings for aggregate safety reports
To undertake other activities and projects as required by the line manager

Skills and Requirements:

Graduate level education (life science, pharmacy or nursing degree would be an advantage) or strong prior experience of data entry / data management
Good knowledge of global safety databases, data entry practices, medical coding dictionaries and experience of ARISg and agXchange an advantage
Previous experience in a pharmacovigilance role and/or experience of working with reporting applications such as Business Objects is desirable
Excellent communication skills
Good attention to detail
A strong sense of responsibility and a good track record of working to strict deadlines and supporting others with similar work
Strong organisational skills
Ability to work independently when required
Flexibility, adaptability and proactivity

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Divya Mistry on +44 203 814 1315 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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