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Medical Adviser

Our very renowned and respected client based in London is looking for a Medical Adviser to join their expanding team on a permanent basis.

The Medical Adviser will be reporting into the Head of Medical Services.

PURPOSE OF ROLE

�To review key clinical trial data documentation
�To advise study and project teams on medical matters related to Phase I and II clinical trials in oncology.


KEY RESPONSIBILITIES

1. Pharmacovigilance Medical Review
�Responsible for day to day medical review of all Serious Adverse Event (SAE) reports on 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
oInvestigator Brochures,
opatient information sheets,
oconsent forms,
oClinical Study Reports (CSRs)
oAnnual 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.

3. Standards and Standard Operating Procedures (SOPs)
�Conduct and document all work as described in the relevant SOPs
�To write, review and comment on SOPs as required

PERSON SPECIFICATION

Qualifications and Experience

dKey Personal Qualities

�Excellent interpersonal skills
�Ability to work on own initiative
�Ability to maintain rigorous adherence to written procedures, guidelines and legal requirements
�Ability to solve problems within own remit and know when to intervene, and when to escalate problems to HMS
�Good communication skills in order to liaise effectively with staff and external collaborators and authorities.
�Ability to handle and manage information effectively
�Excellent attention to detail
�Good planning and organising skills
�Ability to influence and negotiate with others.
�Excellent written English