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Drug Safety Associate In Connecticut (Remote)

3-5 years
Not Disclosed
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

Position: Drug Safety Associate

Location: Connecticut (Remote)

Job Description:
The Drug Safety Associate will be responsible for processing adverse events in support of the Case Management function within Drug Safety Operations.

Primary Responsibilities:

  • Execute case processing activities, including triage, data entry, and report distribution as required.
  • Assess, process, and enter data for all adverse event (AE) case types to ensure compliance.
  • Perform triage to prioritize all case types as needed.
  • Identify adverse events, assess seriousness, and determine labeled status for reportability; review additional incoming information as necessary.
  • Select appropriate causality assessments (both as-reported and company-specific).
  • Conduct coding using MedDRA, WHO-DRUG, and company product dictionaries.
  • Create and manage case narratives for medical orientation as required.
  • Determine follow-up needs and request additional information through email, phone, or letters.
  • Conduct quality control activities for CRO cases, including reconciliation as needed.
  • Support Individual Case Safety Report (ICSR) submissions and transmissions.
  • Focus on high-priority cases using the Workflow Management System or as directed.
  • Participate in inspections and audits, including interviews and provision of requested data.
  • Achieve key performance indicators (KPIs) and quality indicators (KQIs) set by the client while adhering to company guidelines.
  • Assist in drafting late ICSR-related deviations and corrective and preventive actions (CAPAs) upon request.
  • Take on 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).
  • At least 5 years of experience in a pharmaceutical or biopharmaceutical setting.
  • Minimum of 3 years in a Drug Safety Operations role.
  • Experience overseeing CRO teams of case processors is preferred.
  • US FDA pharmacovigilance inspection experience is a plus.

Necessary Knowledge, Skills, and Abilities:

  • Strong resource and workflow management skills, with the ability to monitor and assign tasks effectively.
  • Up-to-date knowledge of US and international pharmacovigilance regulations and best practices.
  • Proficient in MedDRA coding.
  • Ability to consider 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.

Possible Relevant Titles:

  • Seasoned PV Lead
  • QC Associate on a CRO Team

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