Drug Safety Operations Associate - Remote / Telecommute

3-5 years

$48.36 to $53.36 per hour

Remote, USA

10 Sept. 27, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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 Description

Pay Range: $48.36/hr - $53.36/hr

Responsibilities:

Perform case processing activities, including triage, data entry, and report distribution as needed.
Assess and process all adverse event (AE) case types to ensure compliance with regulatory requirements.
Triage cases to prioritize as requested by the company.
Identify adverse events, their seriousness, and their labeled status for proper case assessment, reviewing incoming information for reportability.
Select the appropriate causality assessments (as-reported and company causality).
Conduct all necessary coding using MedDRA, WHO-DRUG, and company-specific product dictionaries.
Create and manage case narratives as needed for medical orientation.
Determine follow-up requirements and initiate requests for additional information via email, phone, or letters.
Execute CRO case quality control activities, including reconciliation as required.
Support Individual Case Safety Report (ICSR) submissions and transmissions as needed.
Work on high-priority or assigned cases using the Workflow Management System or as directed.
Participate in inspections and audits, including providing requested data and participating in interviews.
Meet key performance indicators (KPIs) and quality indicators (KQIs) as set by the company, adhering to guidelines and policies.
Assist in writing late ICSR-related deviations and corrective and preventive actions (CAPAs) as requested.
Perform additional tasks as assigned, working independently to assess issues, propose solutions, and escalate matters internally as appropriate.

Education and Experience Requirements:

Bachelor’s degree in a life science or healthcare field (advanced degree preferred).
Minimum of 5 years of experience in a pharmaceutical or biopharmaceutical company.
At least 3 years of experience in Drug Safety Operations.
Experience overseeing CRO teams of case processors is preferred.

Knowledge, Skills, and Abilities:

Strong resource and workflow management skills, with the ability to monitor and assign tasks effectively.
Proficient in MedDRA coding.
Ability to consider both present and future impacts when making recommendations.
Strong negotiation and problem-solving skills.
Excellent analytical skills and attention to detail.
High accountability and ownership of deliverables.

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Drug Safety Operations Associate - Remote / Telecommute

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