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Irfa******
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United States
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Last Update: 12.06.2019 at 10:17
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
225 South Lake Avenue, Suite 1050, Pasadena, CA 91101, US
Country
United States
Category
Description
Responsibilities: Represent as head of safety operations and compliance in drug development program meetings for all Arrowhead investigational products. Represent safety compliance on the cross functional QA/Compliance team. Ensure overall planning, oversight and timely development and submission of safety-related regulatory documentation including DSURs, IND annual reports, or other global or national periodic safety reports. Assist in the response to regulatory agency or IRB/EC safety related queries. Lead the review and manage the development and maintenance of Clinical Risk Management Plans (CRMPs) for all clinical studies. Prepare and maintain study specific Safety Monitoring Plans. Accountable for the establishment and oversight of an external global safety reporting vendor. Partner with QA and Clinical Operations to ensure appropriate oversight of safety reporting /pharmacovigilance activities performed by CROs. Collaborate on periodic audit compliance activities to ensure compliance with regulatory reporting requirements. Initiate and implement correction plans as required. Collaborate in the development and communication of safety related information to health care professionals, investigators, regulatory agencies etc. Collaborate in the review and development of written materials including clinical trial protocols, ICFs, Case Report Forms AE/SAE Reporting forms, CSRs, IBs (including RSI determinations). Represent Arrowhead as the point person for unblinded/blinded safety case management. Provide drug safety case management support to the medical monitors; liaise on development of specific query development, signal detection, case reports and analyses, as needed. Collaborate with Clinical Operations on the development of DSCs, DSMBs and associated charters ensuring timely and accurate communication of unblinded safety reports as required. Collaborate with Data Management on the development and implementation of data management systems for the aggregate safety data collection, monitor and signal detection appropriate for Arrowhead’s business model and short/long term business needs. Act as designated company safety contact to external vendors for the management of safety reports and compliance issues arising from Arrowhead clinical trials. Provide guidance on day to day safety reporting quality issues and data management issues. Ensure adherence to CRO contracts for safety/PV services across all clinical programs. Assist, and where appropriate lead, in the management of Agency pharmacovigilance inspections including interviews as well as providing inspectors with the requested information or material relating to safety/pharmacovigilance reports and activities. Development and implement safety surveillance procedures for Arrowhead’s clinical development products, to ensure corporate compliance with national and international adverse event reporting requirements. Act as meeting manager to Arrowhead’s Safety Review Committee ensuring timely assessment and management of safety signals or medical issues. Develop and lead a future team of safety operations staff aligned with Arrowhead’s business growth and expansion.