Drug Safety/Medical Information Specialist jobs in New Jersey

Company Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.

• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

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 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.

Additional Information

All your information will be kept confidential according to EEO guidelines.