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Exposure to clinical data coding classification systems, e.g., MedDRA, LOINC, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Meta-Data Repository. Exposure to clinical data coding classification systems, e.g., MedDRA, LOINC, WHO-Drug, Data Standardization (CDISC STDM &/or ADAM), Meta-Data Repository.
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Perform MedDRA coding of all AEs as reported in source documents. US support currently includes Annual sponsorship of the MoMA film program, Tribeca Film Festival programs and Through Her Lens, Support of the Academy Gold Fellowship for Women and Sponsorship of the BAAND Together Dance Festival at Lincoln Center.
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Utilize MedDRA & WHODRUG codes for reporting. Piper Companies (Health & Sciences) is seeking motivated candidates for a Medical Monitor and/or Safety & Pharmacovigilance Specialist opportunity in the Montgomery County, MD area to support a well-established research organization focused on providing biopharmaceutical development support, health information services, and health & environment assessments for commercial and government clients.
$75ExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Extensive knowledge of ICH guidelines, safety systems (e.g. ARISg and Argus) and MedDRA. Author safety assessment reports as well as other safety documents and regulatory responses in collaboration with the Global Safety Officer (GSO.
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Certified MedDRA Coder (CMC) examination completion is a plus. Knowledge and experience working with industry standard coding dictionaries, e.g. MedDRA, WHODrug. Experience in technologies such as Medidata modules (RAVE, Coder, RTSM, eCOA), Veeva eTMF, eClinical Solutions Elluminate, SAS LSAF.
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Clinical/medical review of SAEs, SUSARs, Analysis of Similar Events for SUSARs, as required, including reviewing the source records, reviewing the case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event "expectedness" based upon the reference safety information, preparation of sponsor assessment, and assisting drug safety staff in determining reportability.
$275,500 - $297,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Excellent understanding of the pharmaceutical industry and the future trends and developments in Drug Safety Pharmacovigilance. Demonstrates the ability to provide input into study-related activities and documentation, regulatory submissions, DSURs, ISS, responses to regulatory agency inquiries, pharmacovigilance processes and projects, preparation of aggregate safety reports, risk management plans and experience with pharmacovigilance audits and inspections.
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Good understanding of database and dictionary structures (e.g., MedDRA) Working understanding of GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM Best Practices.
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Safety management responsibilities required for clinical study program oversight inclusive of adverse event adjudication, MedDRA coding, and management of escalation of events to Complaints and reporting to ethics boards per their requirements.
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Perform periodic MedDRA and WHO Drug upgrades. Prior experience in Pre-marketing Drug Safety/Pharmacovigilance Operations. Minimum of Bachelor’s degree in Life Sciences, Healthcare, or relevant field/ equivalent qualification with 8 years of experience working in Drug Safety/Pharmacovigilance Operations.
$120,000 - $155,000 a yearFull-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
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Demonstrated proficiency in drug safety databases (e.g., Argus), electronic data capture systems, and coding with MedDRA and WHO Drug dictionary. 10+ years of experience in drug safety/pharmacovigilance within global clinical trial settings, with expertise in FDA, EU, ICH regulations, and Good Pharmacovigilance Practice guidelines.
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Excellent knowledge of MedDRA coding and WHODrug coding. This position will provide leadership and direction to the Drug Safety operations for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Cytokinetics clinical trials.
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Extensive experience in ICSR management/processing, aggregate safety reports, Argus Safety Database and MedDRA coding. Executive / Senior Director, PV & Drug Safety Operations & Compliance 2007962 Location: Boston, MA (Remote) Therapeutic Areas: Undisclosed Job Overview: This job involves leadership in Drug Safety and Pharmacovigilance, building a team, providing strategic leadership in safety surveillance, and overseeing various aspects of pharmacovigilance operations.
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Intermediate knowledge working with a safety database for retrieval of safety information; Advanced knowledge of MedDRA; MS Office Suite: Advanced application capability with Excel, PowerPoint, and Word. Familiarity with data mining tools and exploratory analyses tools such as Spotfire.
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Experience working with a drug safety database, with working knowledge of MedDRA and familiarity with common safety databases (e.g. ARISg, Argus, AERS) Experience working with a drug safety database, with working knowledge of MedDRA and familiarity with common safety databases (e.g. ARISg, Argus, AERS.
$113,900 - $134,000 a yearFull-timeExpandApply NowActive JobUpdated 2 days ago
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