medical surveillance specialist in inverness

01 February 2019
ruby willard, randstad cpe
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inverness, scotland
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ruby willard, randstad cpe
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job description

Are you an experienced Medical Surveillance Specialist looking for a new role? We are recruiting for a Medical Surveillance Specialist to work on a contract basis for a leading client of ours in the Inverness area.

You will be expected to work independently but with general supervision to prepare and submit Medical Device Reports (MDRs) to global Health Authorities. Ensures global reportable complaints for our client are processed and submitted accurately, and on time to global Health Authorities. You will also be acting as a resource for Customer Quality regarding Potential Reportable complaints.

This is a contract role offered initially on a 6 month basis.


* Investigating and resolving eMDR functionality issues (working with the complaint handling Technical team and/or FDA)
* Compiling monthly reports to Authorized Representatives, EU Statistics and monthly report to AR/LCC, EU Finals Query and submission, MORE database account/management, SGS lancing device report - EU-specific
* Standard Responses to inquiries from Global Health authorities
* Running queries and reports for MDR Monitoring, Bench Failures and Retain Failures.
* Escalate documentation errors to Customer Service and Product Analysis for correction
* Reviewing and addressing Customer follow-up contacts for reportability
* Managing storage of MS records such as Monitoring/Verification reports, PSR, etc. in Enable
* Forwarding Voluntary Medwatch forms received from FDA to Customer Support, including Scanning and Dating the receipt of the information
* Support department trainer with new-hires.
* Managing reports like the Counterfeit Report, Periodic Summary Report (China), Quarterly Adverse Event report to 3rd party vendors, Compiling Rule out Review reports and the Weekly Alert vs. Created Date report.
* Review and respond to void requests from Customer Services
* Manual update of UAE and SA MFs
* DHR (Device History Records) Requests
* Entering Health Authority reference numbers in Complaint Handling database
* Responsible for other duties assigned, as needed

Qualifications and experience required:

* Degree in Health related Science or Life Sciences; or be licensed, registered, or certified to administer Health Care
* Experience in a medical field, patient education, or as a LifeScan Customer Service Representative
* Sound business judgment and ability to make independent decisions to ensure compliance with FDA and global Health Authority reporting requirements
* Excellent verbal and written communication skills in English
* Excellent attention to detail
* Excellent interpersonal, problem-solving, and organizational skills
* Proficient in the use of technology including keyboarding, PC's, Internet, word and excel processing, email functionality, etc
* Fluency in an additional language (especially Spanish) would be an asset but is not required
* Knowledge of diabetes and medical terminology strongly preferred

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.