Drug Safety Specialist

Drug Safety Specialist
Company:

Software Guidance & Assistance


Drug Safety Specialist

Details of the offer

Location: Madison, NJ
Bill : $50.12 HR

Essential Duties and Responsibilities:

Support activities required for root cause analysis and CAPA monitoring.

Support the production of compliance metric reports.

Support the production of quality metrics reports.

Liaise with LDSO Drug Safety Managers and Case Management staff to resolve potential compliance findings.

Support QA random samplings.

Support the review of local ICSR 15-day submission decisions.

Support maintenance and contribute to the development of QA Tracking Log.

Support the development of quality performance metrics and analysis of quality issues.

Support the identification and tracking of action items and plans to correct quality issues.

Support activities required to monitoring compliance of PV related contractual obligations including report reconciliation.

May support the execution of departmental projects.

Job Requirements:

Bachelor's degree (BS) or the equivalent combination of relevant professional experience. Bachelor's degree preferred.

One year of pharmacovigilance experience

Good organizational and time management skills

Ability to multi-task and prioritize

Good communication skills (written/oral)

Attention to detail

Good computer skills including experience with Microsoft Office

Strong identification with Celgene's values

Knowledge:

Awareness of regulatory requirements related to pharmacovigilance

Awareness of the link between regulations, drug development and drug safety.

Awareness of the role of compliance in drug safety.

Awareness of the use of databases and other software applications.


Source: Dice


Area:

Requirements

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