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Quality Specialist, Pharmacovigilance - C1 French Speaker

Employer
Labcorp Drug Development
Location
HOMEWORKING
Salary
Competitive
Start date
6 Jan 2023
Closing date
5 Feb 2023

View more

Discipline
Clinical Research, Drug Safety
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details

Quality Specialist - Patient Safety Services - C1 French Speaker

Are you a C1/fluent French speaker looking for a new challenge within Patient Safety, specifically surrounding the quality review of cases, in a global CRO? Looking to play a key role in ensuring the quality of assigned pharmacovigilance projects, process improvements and audit readiness?

Due to continuous growth and demand we are hiring a Quality Specialist to work closely with QA Management, internal/external clients and vendors or suppliers of Labcorp.

Ideally you will also have experience mentoring and providing error training to colleagues but quality review training can be provided.

The position will be full time and 100% remote within Bulgaria or Romania.

Language Skills Required:
  • Speaking: Fluency in English and local language plus French, C1 level minimum.
  • Writing/Reading: English and local language as well as either of the above.


Responsibilities
  • Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables.
  • Ensure compliance of operations with governing regulatory requirements.
  • Perform Quality review of assigned cases.
  • Assist in compiling quality metrics based on this review and identifying quality trends.
  • Assist in addressing periodic client quality reviews.
  • Assist in preparation of Corrective and preventive actions as requested.
  • Assist in ensuring that CAPA results are implemented and produce documentary evidence to that effect in coordination with the project managers.
  • Assist in the conduct of process review for assigned process and measure and monitor audit readiness.
  • Assist in designing and tracking training schedule and training material for new hires and existing team.
  • Contribute to discussion forums on Quality errors within assigned project and help identify process improvements.
  • Assist in coordinating respective client or external audits of the assigned projects as requested.
  • Assist in development of Quality Management Plan for assigned project.
  • Coordinate with the project team to support the Client during regulatory inspections at client sites with support from Quality Lead / Quality Manager.


Education
  • Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences.

Experience
  • Relevant safety experience, similar to duties above and ideally experience handling calls/cases.
  • Any peer review or quality review experience in a contact centre environment would be advantageous.
  • Knowledge of regulatory requirements and applicable EU and FDA guidelines.
  • In-depth understanding of case processing and assessment.


#LI-Remote

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement .

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

hub-icon-labcorpPlease visit our Careers Hub on

https://www.pharmiweb.jobs/minisites/labcorp-drug-development-careers-hub/

 

 

 

Find Us
Website
Mini-site
Labcorp Drug Development
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
GB
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