MSI Pharma are partnering with an exciting biopharma based in California to source an experienced PV Operations Manager, at an Associate Director level. The main responsibilities for this role is:
Manage Vendor Oversight including tracking of KPIs, metrics and QC of SAE/ICSR cases in Safety database.Manage SAE/SUSAR reporting activities for all investigational drugs.Manage preparation and processing of internal and external SAE reports.Review incoming adverse events to determine action required.Oversee maintenance of an externally hosted electronic safety database for tracking, storing, and reporting of serious adverse events from clinical trials.Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs.Overall accountability of partnership collaboration on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance AgreementsLead preparation of safety-related plans with partners and CROsProvide guidance and support to project teams for safety-related areas, including protocol development and study conduct.Contribute to preparation of relevant sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents.Assist with preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, etc.Lead Staff PV training and external CRO's on drug safety principles and procedures, including training GVP Modules and key relevant US & EMA safety-related Guidance documents and procedures.Manage and mentor staff and assign responsibilities as appropriate to meet timelines and quality metrics.Respond to safety-related queries from regulatory authorities or Ethics Committees, if neededCollaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities.Support the development and review of appropriate safety sections of key product documents including: IBs (including RSI determination), study protocols, ICF, CSRs, CCDS, RMP, REMSSupport review of individual case safety reports (ICSRs/SAEs) throughout the life cycle of products, including narrative review of SUSARs, and including generation of Analysis of Similar Events as needed.Perform ongoing review TFLs and AE data from ongoing studies to evaluate common AEs, lab abnormalities, and summarize the results in the product safety reports.Support safety data review and analysis, summarize safety data in support of regulatory submission activities, signal detection and management activities, or in response to ad hoc safety inquiries from health authorities, track all safety related activities.Support projects or other initiatives from cross functional groups and departments (Clinical Development, Regulatory Affairs, Quality and Toxicity), ensure adequate safety support and timely update of safety information to drug safety physicians.Supports the development of Drug Safety infrastructure, including new safety projects and set-up of safety systems applicable to safety data from the medical and scientific perspective.May also participate in other activities as required to support the day-to-day functioning of the Drug Safety group.
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