Senior Process Associate
CurrentAccountable for handling ICSRS/E2B files received via data exchange systemsdisposition of valid items into ARIS from IRT for further processing in ARIS.Acknowledging receipt of ICSRS to sender within the timelines documented in the relevant SOP. Handling invalid items in IRT appropriately through reference to SOPs, relevant training and the ARIS user manual. Accountable for performing accurate data capture for ICSRs which can be spontaneous, clinical, literature or legal in origin. Accountable for performing the appropriate clinical assessments (including seriousness, labeling and company causality for each adverse event) as per SOPs/other controlled documents and regulatory requirements. Responsible for identifying duplicate/invalid ICSRs in ARIS and handling as per relevant SOP. Responsible for generating and forwarding appropriate queries and requests for clarification and/or follow up information. Performing in clinical trial reconciliation process, as well reconciliation activities associated with Safety Data Exchange & Pharmacovigilance Agreements. Assuring and maintaining compliance with regulatory and local/global SOP timelines. Representing Drug Safety in regulatory and internal inspections and audits as required. Developing and maintaining knowledge of the appropriate disease biology areas and associated Roche product knowledge. Demonstrated knowledge of safety concepts, global regulatory reporting obligations, relevant PDSO SOPs, PVA and SDEA.Responsible for collaborating with Drug Safety Personnel to stay informed about critical Adverse Events (AEs), labeling documents, and other company product. Responsible for creating and maintaining Data Handling Guides for assigned molecules. Performing end of study blind break activities. Supporting submission related activities.Handling invalid AR line listing received from BP periodically. Reviewing safety sections of the eCRF and eTMF.
