Job Description
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 environment. The 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.
- 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.
- Create targeted follow-up letters.
- Review and update generated follow-up letters as appropriate.
- Perform major modifications following Medical Review.
- 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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
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