PRAHS

  • Senior Drug Safety Process Manager

    Job Locations (All) | US-MA-Boston
    Posted Date 3 weeks ago(10/26/2018 2:49 PM)
    ID
    2018-50080
  • Overview

    Monitor performance of quality systems to ensure effectiveness and efficiency. Communicate quality control information to all relevant organizational departments, outside vendors, or contractors. Analyze quality control test results and provide feedback and interpretation to production management and staff. Ensure adverse event information is processed according to company timelines and quality standards. Perform case report QC, review, follow-up and reportability assessments. Responsible for regulatory submissions for ICSRs from the Global Safety database and on-time delivery of adverse event reports to global Health Authorities, alliance partners, and SAE communication to ECs and investigators. Adjust day-to-day PV operations department work and resources to meet timelines. Provide first-line support, trouble-shooting, training, and mentoring for issues related to case intake, import, entry, export, and distribution. Communicate with alliance partners and CROs regarding the evaluation and processing of ICSRs. Review and approve alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements. Responsible for compliance with global regulatory requirements by adhering to appropriate SOPs and business processes. Responsible for reconciliation processes for case exchange between alliance partners and local operating companies (LOCs). Support LOCs in PV activities related to queries and requests regarding case handling. Prepare Pharmacovigilance SOPs, procedure documents, and training material. Supervise and provide training to Pharmacovigilance applicable vendors. Implement process improvements to insure a high standard of ICSR quality is maintained. Serve as the subject matter expert for PV literature surveillance and oversees the processing of literature ICSRs by the vendor. Collaborate with PV Systems to evaluate potential new relevant technologies as required.

    Responsibilities

    Monitor performance of quality systems to ensure effectiveness and efficiency. Communicate quality control information to all relevant organizational departments, outside vendors, or contractors. Analyze quality control test results and provide feedback and interpretation to production management and staff. Ensure adverse event information is processed according to company timelines and quality standards. Perform case report QC, review, follow-up and reportability assessments. Responsible for regulatory submissions for ICSRs from the Global Safety database and on-time delivery of adverse event reports to global Health Authorities, alliance partners, and SAE communication to ECs and investigators. Adjust day-to-day PV operations department work and resources to meet timelines. Provide first-line support, trouble-shooting, training, and mentoring for issues related to case intake, import, entry, export, and distribution. Communicate with alliance partners and CROs regarding the evaluation and processing of ICSRs. Review and approve alliance partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements. Responsible for compliance with global regulatory requirements by adhering to appropriate SOPs and business processes. Responsible for reconciliation processes for case exchange between alliance partners and local operating companies (LOCs). Support LOCs in PV activities related to queries and requests regarding case handling. Prepare Pharmacovigilance SOPs, procedure documents, and training material. Supervise and provide training to Pharmacovigilance applicable vendors. Implement process improvements to insure a high standard of ICSR quality is maintained. Serve as the subject matter expert for PV literature surveillance and oversees the processing of literature ICSRs by the vendor. Collaborate with PV Systems to evaluate potential new relevant technologies as required.

    Qualifications

    Bachelor’s degree in Pharmaceutical Science, Healthcare, Drug Safety, or related field and four (4) years’ experience in the offered role or in Pharmacovigilance, Clinical Operations, Regulatory Affairs, or related role. Four years' experience in: regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment; leading teams in matrix environment; negotiation and consensus decision making; PV regulations for the global pre- and post-market; global safety databases, MedDRA coding, and WHO drug dictionaries including performing searches with advanced conditions; and computer literacy with Microsoft applications. Three years' experience in: external partner relationship management; and medical and scientific terminology.

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