PV Physician - Part Time - UK

Reference No: J6301

PV Physician Job - Part Time
(3 days a week)

An exciting opportunity has arisen for a Medical Advisor to join this world leading organisation specialising within oncology. This dedicated and experience directorate working in collaboration with scientists, clinicians and companies is an excellent opportunity for a medically qualified individual with clinical experience who has an interest in developing their knoweldge and experience around the establishment, regulation and reproting of oncology clinical trials.

Key responsibilities will include:-

1. Pharmacovigilance Medical Review

Responsible for day to day medical review of all Serious Adverse Event (SAE) reports on the companies sponsored trials
Work closely with the Pharmacovigilance Manager regarding review of SAEs and other safety data.
Provide causality assessment of SAEs to study drugs
Ensure SAE reports are medically correct and that diagnosis / signs & symptoms are recorded and coded accurately
Review SAE cases to identify any further follow up information required
Responsible for day to day medical review of all SAE reports received from business partners on trials of the same drug to assess their impact on trials
Identify the need for safety information to be updated e.g. in Patient information Sheets, Investigator Brochures
Review line listings of study-specific Adverse Events / SAEs for safety trends and issues
Review lists of study specific AEs / SAEs to identify expected events and medically important events
Identify safety issues and escalate them to the Head of Medical Sciences (HMS)
To provide medical review and input into clinical trial Annual safety reports (ASRs)

2. Clinical Study Operations / Project Management

To provide medical advice to the clinical study and project teams
To provide medical input into clinical trial documentation, including
Investigator Brochures,
patient information sheets,
consent forms,
Clinical Study Reports (CSRs)
Annual Safety Report (ASRs)

To conduct regular meetings with Clinical Study Managers (CSMs) to review study status
To provide regular, written updates on trials to HMS
To escalate decisions on clinical trial eligibility to HMS
To support HMS in preparation and conduct of the Central Institutional Review Board (CIRB).
To attend committees, as required, and provide medical input and opinion.

Qualifications and Experience

Essential

Current registration with the General Medical Council (GMC) to practice medicine in the UK
Previous clinical experience
Membership of the Royal Colleges of Medicine

Advantageous

A higher research degree
Working knowledge of Pharmacovigilance procedures
Experience of working on Phase I and/or Phase II studies in oncology
Working knowledge of ICH/GCP and clinical trial methodology

If you would like to apply for this position please contact Spencer Marsh on 01189 522799 or email spencer@onlymedics.com.

Keywords:-

Oncology, Cancer, Physician, Clinical Research Physician, Medic, Senior Medical Adviser, Medical Adviser, Medical Advisor, London, Clinical Research.

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