Drug Safety Specialist III

Karwell Technologies

Remote, NJ(remote)

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JOB DETAILS

SKILLS

Adverse Events, Analysis Skills, Best Practices, Biology, Biotech and Pharmaceutical, Contract Research Organization (CRO), Corporate Compliance, Corporate Policies, Data Entry, Data Processing, Detail Oriented, Drug Products, Establish Priorities, FDA (Food and Drug Administration), Healthcare, Medical Dictionary for Regulatory Activities (MedDRA), Negotiation Skills, Nursing, Patient Assessment, Performance Metrics, Pharmacovigilance, Pharmacy, Problem Solving Skills, Process Analysis, Quality Control, Reconciliation, Regulations, Regulatory Compliance, Report Distribution, Resource Management

LOCATION

Remote, NJ

POSTED

30+ days ago

Responsibilities:

Perform case processing activities (triage, data entry, report distribution) as required.
Assess, process, and data enter all AE case types to meet compliance requirements.
Perform triage on all case types to determine prioritization (if requested by Purdue).
Identify adverse events, seriousness, and listedness / labeledness for case assessment; review additional incoming information to determine reportability.
Select the appropriate as reported causality and company causality.
Perform all appropriate coding using MedDRA, WHO-DRUG, and Company Product dictionaries.
Own case narrative - create narrative text as required for medical orientation.
Determine follow-up requirements and request follow-up as appropriate (e-mail, phone call, letter, etc.) to request additional information.
Perform CRO case QC activities, reconciliation etc. as required.
Work on highest priority or assigned cases using Workflow Management System, or as directed.
Support PV inspections and audits as identified, including interviews and provision of requested data.
Monitor vendor KPIs/KQIs as designated by Purdue and in compliance with company guidelines and policies.
Perform additional tasks as assigned. Work independently, assess matters, propose resolutions, and appropriately escalate internally within Purdue organization.

Requirements:

Bachelor's degree (advanced degree preferred) in life science or healthcare (e.g., nursing, pharmacy).
Minimum 5 years of experience in a pharmaceutical/biopharmaceutical company.
Minimum 3 years in Drug Safety Operations role.
Experience overseeing CRO teams of case processors preferred.
US FDA pharmacovigilance inspection experience preferred.

Necessary Knowledge, Skills, and Abilities:

Resource and workflow management (monitoring and assigning tasks).
Up-to-date knowledge of US and international PV regulations and best practices.
MedDRA coding.
Considers present and future impacts when making recommendations.
Strong negotiation and problem-solving skills.
Analytical skills and attention to detail.
Accountability takes ownership of deliverables.

About the Company

Karwell Technologies

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