Jpc - 176180 - Drug Safety Associate In Connecticut (Remote)

5+ years

Not Disclosed

Stanford

10 Nov. 26, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Adverse Event Processing Specialist (Drug Safety Operations)

Location: [Insert location]

Company: [Insert company name]

Job Overview:

We are seeking a qualified Adverse Event Processing Specialist to support the Case Management function within our Drug Safety Operations team. This position will focus on processing adverse event (AE) reports, ensuring compliance with regulatory requirements, and performing quality control (QC) tasks to maintain high standards. The ideal candidate will have experience in pharmacovigilance, specifically in adverse event processing, and will work independently to prioritize and assess cases, ensuring timely and accurate reporting.

Primary Responsibilities:

Adverse Event Processing:
- Perform all aspects of adverse event case processing, including triage, data entry, and report distribution.
- Assess and process all AE case types to meet compliance requirements.
- Perform triage to determine the prioritization of incoming cases.
- Review incoming information to determine reportability and ensure the correct identification of adverse events, seriousness, and listedness/labeledness.
- Select the appropriate causality assessments (as reported and company causality) for each case.
Coding and Narrative Creation:
- Perform appropriate coding using MedDRA, WHO-DRUG, and Company Product dictionaries.
- Create and maintain case narratives with a medical orientation as required.
Follow-up and Documentation:
- Determine follow-up requirements and request additional information from relevant parties (via email, phone, letter, etc.) when necessary.
- Support the preparation and submission of Individual Case Safety Reports (ICSRs).
CRO and Quality Control:
- Oversee and perform CRO case QC activities, ensuring the accuracy of data and adherence to timelines.
- Assist in the reconciliation process as needed.
- Participate in audits and inspections, including interviews and providing requested documentation.
Process Improvement:
- Ensure KPIs/KQIs are met and follow all internal and client-specific guidelines and policies.
- Assist in writing and addressing deviations and CAPAs related to late ICSR submissions.
Additional Tasks:
- Work independently and propose resolutions to issues, escalating appropriately within the client organization.

Education and Experience Requirements:

Education:
- Bachelor’s degree (advanced degree preferred) in life sciences, healthcare, or a related field (e.g., nursing, pharmacy).
Experience:
- Minimum 5 years of experience in the pharmaceutical/biopharmaceutical industry.
- At least 3 years of experience in Drug Safety Operations or pharmacovigilance.
- Experience overseeing CRO teams of case processors is preferred.
- Experience with US FDA pharmacovigilance inspections is a plus.

Necessary Knowledge, Skills, and Abilities:

Resource & Workflow Management: Ability to monitor and assign tasks effectively within the team.
Up-to-date Knowledge: Understanding of US and international pharmacovigilance regulations and best practices.
MedDRA Coding: Proficient in MedDRA coding and relevant industry-standard coding systems.
Problem-solving & Negotiation Skills: Strong ability to assess situations, propose solutions, and negotiate as required.
Analytical & Detail-oriented: High attention to detail in reviewing adverse events and ensuring compliance.
Accountability: Ability to take ownership of deliverables and meet deadlines.

Possible Relevant Titles:

Senior Pharmacovigilance Lead
QC Associate (CRO team)
Drug Safety Lead
Adverse Event Case Processor

Key Performance Indicators (KPIs):

Timely and accurate case processing.
Meeting or exceeding client-defined KPIs and KQIs.
Successful resolution of adverse event cases with minimal errors.
Active participation in audits and inspections.

Why Join Us?
This is an excellent opportunity to contribute to the safety and compliance of pharmaceutical products. We offer a dynamic work environment with opportunities for career growth in the evolving field of pharmacovigilance and drug safety. If you have a passion for ensuring patient safety and thrive in a collaborative setting, apply today!

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Jpc - 176180 - Drug Safety Associate In Connecticut (Remote)

Job Description

Job Overview:

Primary Responsibilities:

Education and Experience Requirements:

Necessary Knowledge, Skills, and Abilities:

Possible Relevant Titles:

Key Performance Indicators (KPIs):

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