South Plainfield, New jersey
Drug Safety Specialist Job Opening in South Plainfield, New jersey - JOB DESCRIPTION:
Healthcare professionals (RN) are highly preferred. Experience and capability to deal with high volume of work is required. Candidate MUST be able to produce a high volume of high quality cases within a busy Drug Safety work Drug Safety Specialist is: A regional role based at Summit, NJ reporting (at a minimum) to Associate Director.
Responsibilities:
Ensuring that individual Adverse Event Case Reports are evaluated, investigated and accurately computerised Note = For Contract positions functionality may be narrowly defined based on business needs
AE CASE MANAGEMENT Receipt
Execute receipt of Drug Safety phone calls and complete telephone AE form
Create phone call communication logs in ARISg Triage
Support the triage of cases conducted by Senior Specialist as needed
Assessment
Execute QC on key fields of serious cases
Update key fields in ARISg based on QC, as needed
Execute case assessment (review events, determine labeledness, identify co-manifestations, review coding, determine causality)
Create clear concise clinical case narratives
Review & update auto-narrative as needed
Create company comments
Perform event rankings
Make dechallenge / rechallenge determinations
Determine follow-up needs for AE reports
Create targeted follow-up letters
Review and update generated follow-up letters as appropriate
Perform major modifications following Medical Review
PHARMACOVIGILANCE (APPROVED PRODUCTS) PSURs
Support the identification of corrections and creation of updates in ARISg following medical review
Meets case processing deadlines for aggregate safety reporting
COMPLIANCE, STANDARDS, TRAINING & PROJECT MANAGEMENT
Preparation for Regulatory Inspection
Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
INTERNAL GLOBAL SAFETY DEPARTMENT DEVELOPMENT
Participate in team meetings within the drug safety department
Contribute to the orientation and training of staff as needed.
ARISg or ARGUS experience highly desired. Candidate needs database experience.
The candidate MUST be able to produce a high volume of high quality cases within a busy Drug Safety work environment. Healthcare professionals are preferred.
Job Type: Contract
Required education:
Bachelor's
Required experience:
PHARMACOVIGILANCE (APPROVED PRODUCTS) PSURs: 5 years
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