job details for:
Clinical Research - Senior Drug Safety Specialist Jobs - London

Clinical Research - Senior Drug Safety Specialist Jobs - London (Job Ref: WR/JOBS/24703-11125)

Job Description :

Flame Pharma Clinical Research – Senior Drug Safety Specialist Job - London:

Job Summary

Flame Pharma is working with a leading global bio/pharmaceutical services organisation, providing contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries.  We are recruiting for a Senior Drug Safety Specialist to be the project lead and provide technical and process-related expertise to drug safety/pharmacovigilance management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs), including clinical endpoint processing

Job Title

Senior Drug Safety Specialist

Background

Due to expansion, the Senior Drug Safety Specialist is required to be the project lead and provide technical and process-related expertise to drug safety/pharmacovigilance management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs), including clinical endpoint processing.

Key Responsibilities

• The Senior Drug Safety Specialist will develop project specific safety reporting procedures and workflows and provide guidance to the project team
• The Senior Drug Safety Specialist will lead and manage projects including the development of project specific safety reporting procedures and workflows and provide guidance to the team on the procedures
• The Senior Drug Safety Specialist will develop project specific safety database customization and data entry guidelines
• Participation in signal generation activities
• Triage of incoming reports for completeness, legibility and validity
• Initial data entry of case reports into safety database / tracking system

Experience and Qualifications

• Degree educated
• Considerable drug safety knowledge and experience
• Experience in working in drug development and/or healthcare environment
• Excellent knowledge of drug safety and the drug development process
• Excellent knowledge of and ability to interpret and apply global safety regulations
• Experience in data analysis, evaluation of safety data and the preparation of safety reports
• Excellent team / project leadership and delegation skills

Benefits

This represents a challenging career with a lot of responsibility and excellent opportunities for progression. An attractive remuneration package will be offered to successful candidates including a competitive salary.

Key Words

Senior Drug Safety Specialist, Drug Safety, Pharmacovigilance, Clinical Research, Clinical Trials, Pharmaceutical, Biotechnology, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Job, Opportunity, Vacancy, London

The position will be based in London.

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