Job Description

A highly reputable pharmaceutical corporation is currently looking to hire two qualified Remote Drug Safety Data Coordinators.

• Leads the development and implementation of medical coding in clinical data management systems; participates in management of individual case safety reports (SAEs, AEs of Special Interest, Adverse Drug Reactions), AE/SAE reconciliation and data retrievals from the clinical and/or safety databases; provides support for endpoint adjudication committees.
• Performs consistent coding of adverse events, medical history, concomitant medications and other terms according to the project-specific coding conventions.
• Reconciles SAE/AE between clinical and safety database in accordance with the SAE/AE reconciliation plan and other project-specific guidelines.
• Generates DCFs (Data Clarification Forms) or queries, performs corrections of CRFs, if applicable, and clinical databases in accordance with DCF replies.
• Receives and tracks serious adverse events, adverse events of special interest, and adverse drug reactions reports and forwards them to the sponsor/third party in accordance with project-specific contractual agreement.
• Performs data entry of minimal SAE/ADR data in company’s or sponsor's safety database.
• Queries site or reporter for inconsistent or incomplete information on SAE/ADR report.
• Maintains address lists for submission of safety reports to investigators and EC/IRBs.
• Tracks submission of safety reports to investigators and EC/IRBs in company’s Safety Letter Tracking System.
• Conducts quality review of endpoint dossiers/adjudication forms adhering to the agreed timelines.
• Tracks and reconciles endpoint dossiers/adjudication forms.
• Queries sites for missing or inconsistent information on endpoint dossiers/adjudication forms.
• Interacts with endpoint committee during endpoint review.
• Properly documents all internal and external contacts and communications.
• Consistently meets or exceeds objectives set annually.
• Ensures personal career goals are set each year and progress is monitored for completion
• Performs consistent coding of adverse events, medical history, concomitant medications and other terms according to the project-specific coding conventions.
• Reconciles SAE/AE between clinical and safety database in accordance with the SAE/AE reconciliation plan and other project-specific guidelines.
• Generates DCFs (Data Clarification Forms) or queries, performs corrections of CRFs, if applicable, and clinical databases in accordance with DCF replies.
• Receives and tracks serious adverse events, adverse events of special interest, and adverse drug reactions reports and forwards them to the sponsor/third party in accordance with project-specific contractual agreement.
• Performs data entry of minimal SAE/ADR data in company’s or sponsor's safety database.
• Queries site or reporter for inconsistent or incomplete information on SAE/ADR report.
• Maintains address lists for submission of safety reports to investigators and EC/IRBs.
• Tracks submission of safety reports to investigators and EC/IRBs in company’s Safety Letter Tracking System.
• Conducts quality review of endpoint dossiers/adjudication forms adhering to the agreed timelines.
• Tracks and reconciles endpoint dossiers/adjudication forms.
• Queries sites for missing or inconsistent information on endpoint dossiers/adjudication forms.
• Interacts with endpoint committee during endpoint review.
• Properly documents all internal and external contacts and communications.
• Consistently meets or exceeds objectives set annually.
• Ensures personal career goals are set each year and progress is monitored for completion.
• Responsible for effective and efficient development of the coding conventions and coding dictionary license confirmation forms.
• Manages quality control review of coded data.
• Responsible for effective and efficient development of the SAE/AE reconciliation plan.
• Performs quality control of minimal data entry of safety data into company’s or sponsor's safety database.
• Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately.
• Participates in internal and client meetings.
• Reports project status to project/functional management.
• Adheres to financial and administrative processes, such as managing project budget and timelines, estimation of resource needs and projected hours.

Qualifications :

• Bachelors Degree preferred, Undergraduate degree or its international equivalent, preferably in life science and/or healthcare professional.
• Experienced in medical coding using MedDRA and WHODRUG
• 2+ years of Drug Safety experience highly preferred
• Data Management or Health information Management experience preferred
• Read, write and speak English
• Previous experience using computerized information systems and standard application software (Windows, MS Office).
• Excellent interpersonal, written and oral communication skills.

Company Description

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.