Covance Drug Safety Coordinator Job Opening 2019- Application Details

Covance Drug Safety Coordinator Job Opening 2019

Covance Drug Safety Coordinator. Drug Safety Officer Job Opportunity with the Biggest company Covance. Covance is one of the world’s largest and most comprehensive drug development services. Candidates looking for a good salary and a career in Drug management filed may apply for this job post. Check out all the details

Covance is one of the world’s largest and most comprehensive drug development services companies with more than 11,000 employees in 60 countries. Through its nonclinical, clinical and commercialization services, Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

Level of education required (or experience level which may be substituted for level of education):

– Non-Degree +4 years relevant experience** (or 4 years adjudication experience*)

– Associates Degree + 2 years of relevant experience (or 2 years adjudication experience)

– B/BS Degree + 0 years of relevant experience (0 years adjudication experience)

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

– High degree of accuracy with close attention to detail.

– Functions as a strong team player.

– Ability

to work efficiently with moderate guidance.

– Ability to effectively balance multiple concurrent priorities.

– Strong written and verbal communication skills.

– Basic knowledge of medical terminology desirable.

– Basic familiarity with hospital documentation practices desirable.

– Basic understanding of Good Clinical Practice (GCP).

– Accurate math and spelling skills preferable with an aptitude for handling and proof-reading numerical data.

– Good keyboard skills with knowledge of MS Office and Windows applications beneficial.

Job Description:

-Operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).

– Perform processing of adjudication events. This includes, but is not limited to:

•Maintaining event tracking systems.

•Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g. redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and or documents, generation of queries, query review and closure/re-issue.

•Contacting site personnel to obtain missing data and/or documents.

•Escalating open events for issue resolution and closure, in accordance with relevant Escalation Plan.

•Completing First Review QC Checklists, assembling dossiers..

•Conducting event reconciliation processes.

– Assist with implementation of adjudicator work-flows. This includes, but is not limited to:
•Implementation of adjudicator disagreement resolution processes.

•Implementation of re-review and re-adjudication processes.

•Processing of adjudicator requests for additional documentation.

•Processing of adjudicator notifications of potential un-reported events.

– Assist with preparation of event adjudication status reports and metrics.

– Assist with adjudication committee compilation processes. This includes, but is not limited to:

•Identification and screening of potential adjudicators.

•Collection of signed Confidentiality Disclosure Agreements, CVs, completed Adjudicator Selection Questionnaires, signed Contracts from potential adjudicators.

– Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).

– Build and maintain good working relationships within Adjudication Services department and across functional units.

– Any other duties as assigned by management.

Apply Online

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