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Job Details

Associate, Medical Safety Operations

Company: SciPro
Location: California
Reference: HQ7403
Closing Date: 11 Dec 17
Type: Contract
Salary (£): Negotiable

Job Summary:

On behalf of one of SciPro globals key clients, I have available a 12 month contract role located in California, starting ideally ASAP although can wait depending on the candiate.This contract role encompasses a key role in executing departmental strategy and the day-to-day functions of Medical Safety (MS) Operations.


Essential Duties/ Responsibilities

* Performs internal activities and oversight of outsourced activities for individual case safety report (ICSR) processing and reporting from all sources in compliance and quality according to company procedures and regulatory requirements.
* Ensures that expedited and periodic safety reports to regulatory agencies and license partners are submitted and compliance is tracked.
* Liaises with assigned Clinical Reviewer to ensure that appropriate review and assessment is provided for ICSRs.
* Safety data extraction and production from MS systems for internal partners and regulatory submissions
* Performs receipt and submission reconciliation between license partners and vendors and serious adverse event (SAE) reconciliation between the clinical and safety databases.
* Collaborates with QA on product complaints associated with ICSRs.
* Supports regulatory agency interactions (both written and verbal), inspections, and audits.

If your experience and availablity matches the description, you are currently based in the United States, eledgiable to work in the united states and are set up to work Corp2Corp please apply.

Apply for this job: Associate, Medical Safety Operations

Contact Information:

Address:  Head Office
4th Floor, 150 Leadenhall Street, London
Tel:  +44(0)203 327 3072
Website:  Visit Our Web Site

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