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    Associate Director/Director Safety Surveillance

    Clinical Resource Network (Crn)
    5+ years
    Not Disclosed
    Remote, USA
    10 Aug. 13, 2024
    Job Description
    Job Type: Full Time 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 Title: Associate Director of Drug Safety Surveillance (Remote)

    Company: Clinical Resource Network (CRN), a division of Solomon Page

    Job Overview:

    Our client is seeking an experienced Associate Director of Drug Safety Surveillance to join their team remotely. In this role, you will oversee key safety activities, including signal detection, report authoring, and collaboration with medical directors. You will be responsible for ensuring the effective management of safety signals and periodic safety reports, contributing to the safety sections of critical documents, and supporting overall pharmacovigilance efforts.

    Key Responsibilities:

    • Aggregate Report Authoring: Prepare and author comprehensive aggregate safety reports, including DSURs, PADERs, IND Annual Reports, PSURs/PBRERs, and other global periodic safety reports.
    • Collaboration and Coordination: Work closely with Medical Directors within Drug Safety and Pharmacovigilance (DSPV) and coordinate safety review meetings.
    • Signal Detection: Identify and manage safety signals, conduct signal detection activities, and contribute to safety signal assessment.
    • Document Contribution: Develop and review safety sections of key documents such as Investigator Brochures (IBs), study protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Core Data Sheets (CCDS), Risk Management Plans (RMPs), and Risk Evaluation and Mitigation Strategies (REMS).
    • Safety Report Summarization: Summarize findings in product safety reports and support safety signal detection and assessment activities.
    • Trend Identification: Identify and validate trends and concerns related to both company and competitor products.
    • Literature Surveillance: Perform literature surveillance and review published medical literature.
    • Data Review: Review Tables, Figures, and Listings (TFLs) and Adverse Event (AE) data to evaluate common adverse events and lab abnormalities.

    Required Qualifications:

    • Education: Bachelor’s degree or higher in a relevant field.
    • Experience: At least 5 years of experience in pharmacovigilance within a pharmaceutical or biotechnology company, including pre- and post-approval activities such as safety reporting and signal detection.
    • Global Exposure: Experience with US and global pharmacovigilance practices.

    Why Join Us?

    Clinical Resource Network (CRN), a division of Solomon Page, offers a comprehensive benefits package for our employees and consultants, including medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits. We are dedicated to forming long-term relationships with our clients and providing exceptional talent solutions for the pharmaceutical, biotech, and medical device industries.

    About CRN:

    Founded in 2002, Clinical Resource Network (CRN) specializes in clinical research and talent solutions. We offer services in contract staffing, project staffing, consultative services, and full-time placements. Learn more about us at Solomon Page CRN and connect with us on Facebook and LinkedIn.

    Apply Now!

    If you meet the required qualifications and are interested in this role, we encourage you to apply today. Opportunity awaits!

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