Drug Safety Case Management Specialist

Key People

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Job ID :

12657


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

drug safety, pv, pharmacovigilance, oxford, regulatory, case management, reconciliation, ICSR, E2B


Salary :

£45 - £53 per hour


Date Posted :

22 Aug, 2018



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Drug Safety Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

The Case Management Specialist, Submissions & Reconciliation is responsible for the timely reconciliation and submission of Individual Case Safety Reports (ICSRs) to and from destinations including but not limited to global regulatory authorities, business partners, investigators, and ethics committees.

Responsibilities:
*Monitors the submission work list in the safety database for cases requiring submission or distribution to regulatory authorities and all relevant reporting destinations by case priority and report due date
*Performs ICSR submissions (in E2B form via Gateway/EVWEB and CIOMs/Medwatch) and monitors E2B submission for transmit status
*Initiates and executes back up procedures if necessary to address electronic submission failures
*Performs E2B submission validation check and manages rejected E2B transmissions via Gateway and ensures successful re-transmission as appropriate
*Works collaboratively with Global Case Management in workflow monitoring and coordinates database action items to ensure timely submission and completion
*Performs reconciliation activities including but not limited to receipt of all AEs from Business Partners
*Partners with Global Quality Systems to ensure reconciliation of Product Complaint Investigation Reports

Experience Required:

*BS/BA degree in a health related or biological science related field or Equivalent combination of education and level of experience.
*Knowledge of FDA and international adverse event reporting regulations per ICH guidelines and the ability to interpret and apply applicable regulations to resolve issues.
*Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations.
*Experience with preparation of investigational and post-marketing regulatory reports
*Proficiency in standard desktop software programs (Word, Excel, PowerPoint, Outlook).
*Must have a good understanding of Drug Safety regulations specifically around CFR 314.80.
*Familiarity with signal detection and pharmacovigilance processes a plus.
*Must have experience working with ArisGlobal (ARISg) and/or Oracle (Relsys) Argus.
*Must be self-motivated, detail oriented and able to multi-task.
*Must possess excellent communication (oral and written) and complex problem-solving skills.
*Must have strong interpersonal/organizational skills.
*Must possess the ability to work in a team environment and follow written policies/procedures.
*Must be comfortable in a fast-paced, demanding work environment.
*Flexibility to work outside of normal working hours or on-call arrangements.

For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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