|Job Title:||PV Physician|
|Contact Name:||Alex Young|
|Job Published:||July 20, 2017 10:46|
To provide medical support activities for specified clinical studies for specified customers according to required SOPs, regulations, contracts and quality standards
* Review and input into study documentation including protocol, informed consent form, investigator brochure and clinical study report.
* Provide medical input into regulatory and ethics submissions, including responding to questions.
* Training of the study team in medical aspects of a study as required (indication, protocol, inclusion / exclusion criteria, procedures and assessments).
* Attendance & presentation at Investigator meetings
* Medical monitoring visits to site, as required
* Ongoing medical data review during study (adverse events, laboratory readings, physical examinations).
* Attendance at Data Monitoring Committee meetings, as required.
* Ongoing support of the study team (including site staff, CRAs, non-clinical departments), providing advise on study conduct and responding to questions.
* Consultation with Investigators as required (emergency unblinding due to safety concerns)
* Provision of 24-7 medical contact, as required.
* Contact with sponsor, as required.
* Signal detection based on aggregate data review.
* Advise to sponsor on development plan and study design, as required.
* ICSR processing support:
a. Ongoing medical review and assessment of individual case reports including:
i. Case review for medical sense and completeness, including narrative
ii. Coding review of adverse event, indication and drug
iii. Review of follow-up questions for the reporter
iv. Review of assessment of expectedness against reference safety information
v. Provision of company causality & comment.
* Aggregate Reporting Support:
a. Medical review and input into periodic safety reports, such as Development Safety Update Reports and Periodic Safety Update Reports.
b. Input into and review of other pharmacovigilance documents, as required.
* Project Documentation
a. Initial input into and ongoing review of project-specific Safety Plans, as required.