Drug Safety Physician for a world leading charitable research organisation
London based - Permanent Role
We are looking for the person who is the proverbial needle in a haystack.
We are working on behalf of the leading Uk cancer research charity to find a GMC-registered physician, who has practical experience in oncology and who has a passion for new drug development, particularly the safety aspects of new treatments.
This role will bring the appointee in to contact with the leading UK opinion leaders in oncology. Therefore to be credible in the role, anyone applying must be up to date with the latest theories in oncology treatment, and must be able to speak knowledgeably across the 15 different studies currently underway.
The appointee must have some knowledge of drug safety in a commercial setting and must be able to understand signal detection methods and to apply these effectively.
Rewards in this role are not monetary, but are instead being part of a team developing life-changing treatments for individuals with cancer. Based in London ECI, with easy transport routes this is a role for someone who wants to make a difference.
Job Summary
Provide medical support and input in to the pharmacovigilance (PV) function.
Review serious adverse event (SAE) reports arising from trials.
Maintain the safety profile of study agents, reviewing safety data to identify potential safety issues.
Lead the ongoing safety evaluation process.
Collaborate and work^closely with Medical Sciences to provide a medical input to safety related decisions from a pharmacovigilance perspective.
Review key clinical trial data documentation.
Provide medical training to PV function and study teams
Review of SAE reports
Responsible for day to day medical review of all Serious Adverse Event (SAE) reports on CR-UK sponsored trials within requested timeframes providing:
Causality assessment of SAEs to study drugs.
Reviewing assessments of expectedness against the reference safety information.
Reviewing medical accuracy of reports.
Ensure diagnosis/signs & symptoms are recorded and coded accurately.
Maintenance of safety profile of agents
Ongoing safety evaluation
Input to safety related forums
Review and input to key clinical trial documentation
Standards and Standard Operating Procedures (SOPs)
Supplementary Requirements:
Software Competence: MS Office
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: Some
Flexible Working Hours: Possibility to work 1 day / week from home
Employment Information:
Employer: National charitable organisation
Employment Type: Permanent
Hours: Full Time
Location: UK, London
Plan Start^Date: ASAP
Keywords:
KOL, drug safety, pharmacovigilance, oncology, PVG , Clinical Research, Medical Monitor, Medical Affairs, signal detection
Assigned Consultant: Avril Horn at CSL Recruitment on 01932 234686
Please feel free to call for a detailed Job Description or additional information
Applications are reviewed within 24hrs; applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you applied^for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information^on required location, notice period and expected salary/day rate if you are a new candidate.