Overview:

To provide medical support activities for specified clinical studies for specified customers according to required SOPs, regulations, contracts and quality standards

Responsibilities:

* 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.