Drug Safety Associate In Connecticut (Remote)

3-5 years

Not Disclosed

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

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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Drug Safety Associate In Connecticut (Remote)

Job Description

Position: Drug Safety Associate

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