job details for:
Pharmaceutical - Drug Safety Officer Jobs - Berkshire

Pharmaceutical - Drug Safety Officer Jobs - Berkshire (Job Ref: WR/JOBS/23743-9954)

Job Description :

Flame Pharma Pharmaceutical - Drug Safety Officer Job - Berkshire:

Job Summary

The Drug Safety Officer will contribute to Drug Safety & Pharmacovigilance operations and is responsible for completing some or all of the tasks described below in accordance with company SOPs, Work Instructions, regulatory guidance provided in Clinical Trial Directive, CIOMS VI, ICH GCP and / or relevant national, EU or FDA guidelines.

Job Title

Drug Safety Officer

Background

Due to expansion, our client is looking to recruit a Drug Safety Officer to be based in their offices in Europe.

Key Responsibilities

· Reviewing Case Report Forms (CRFs), AE reports, and spontaneous reports

· Ensuring that AE / ADR reports are transmitted in a timely fashion to regulatory authorities, ethics committees and investigators (where appropriate), and other relevant parties

· Maintaining records to verify that appropriate follow up is made of all AEs and ADRs

· Maintaining written telephone reports of telephone queries

· Maintaining local archive of pharmacovigilance documentation

· Developing project specific AE / ADR reporting procedures on national / international projects.  

· Reporting to the Regulatory agencies in Europe for SUSARs

· Developing project specific detailed workflows on national / international projects

· Working with project managers to create or implement and continuously improve appropriate AE / ADR reporting procedures and tracking systems

· Assisting and having input to the drafting, writing and editing of protocols, CRFs, and other quality documentation regarding the drug safety sections

· Preparing ASRs / Safety Updates

· Performing data entry

Qualifications and Experience

· Life sciences degree or equivalent nursing qualification

· Related experience (gained in a healthcare environment)

· Basic understanding of pharmacovigilance principles and regulations

· Strong interpersonal skills and communication skills (written and oral)

· IT literacy including database management

· A keen, ongoing interest in medicine / pharmaceuticals

· Attention to detail

· Ability to assimilate new information and apply it appropriately

· Good time management skills

· Ability to multi-task and work with pressure to meet tight deadlines

Benefits

With this position comes an attractive benefits package that you associate with a world leader, including pension, healthcare, plus a salary circa £30,000.

Key Words

Drug Safety Officer, Drug Safety, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

This role is to be based in Berkshire.

For further information about this role, please contact Flame Pharma.