Associate Director/ Director

The Position

The Associate Director/ Director, Drug Safety will be responsible for maintaining Arrowhead’s safety database, preparation and review of regulatory reports such as serious unexpected serious adverse reactions (SUSARs) and periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for the clinical programs

Responsibilities

• Lead Case Processing and support safety medical review, generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed and work with CRO to determine when cases are complete and ready to close.
• Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy and legibility.
• Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems
• Prepare, support and track PVAs/SDEAs with partners.
• Monitor compliance with partner Safety related activities needed as per PVA/SDEA.
• Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors.
• Review vendor scope and assist with study level budgets as needed.
• Provide vendor oversight, including tracking KPI’s and collaborate with multiple vendors for process setup & improvements.
• Perform and manage SAE reconciliation between databases.
• Responsible for data clean-up and data migration from vendor Safety database.
• Oversee submission activities for ICSRs and aggregate reports.
• Collaborate with vendors for TMF Safety documents filing and review.
• Manage day to day operation of Safety database.
• Ensure that reported SAE (and events of special interest to include pregnancy and overdose) event reports are received, tracked, evaluated, processed and distributed/submitted in an efficient and timely manner, and in compliance with regulations and Arrowhead Management Plans/SOPs.
• Coordinate with vendors to ensure all internal/external timelines are met per PVA and ensure, potential issues are communicated, and resolution is achieved in a timely manner.
• Support activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators.
• Support other members of Safety Operations and Science personnel and ensure flawless execution of Safety and Pharmacovigilance processes
• Vendor management, manage Safety Vendors, CRO and other external parties helping Arrowhead’s drug Safety and Pharmacovigilance.
• Facilitate the analysis of similar events for expedited safety reports occurring in pre-marketed clinical studies.
• Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations.
• Provide drug safety case management support to Safety medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data.
• Assist with the development and maintenance of departmental SOPs and other procedural documents.
• Support reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety
• Support the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed
• Help in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies
• Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies
• Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety
• Participate in inspection-readiness activities to included document and eTMF support.
• Collaborate with Regulatory personal and CROs to communicate upcoming SAEs requiring expedited submissions to Regulatory Authorities, to include ad hoc reporting responsibilities form Arrowhead Safety.
• Support the Manager of Safety Operations and Head of Clinical Safety in the review and development of written materials including clinical trial protocols, Informed Consent Forms, Case Report Forms, adverse event (AE)/ serious adverse event {SAE) reporting forms, Clinical Study Reports, and Investigator's Brochures (including Reference Safety Information determinations)
• Informs Manager of safety related issues and potential trends and or signals arising from review of post-marketed safety data.
• Assist with safety database test configurations.
• Assist with review of cross-functional documents/plans (e.g., protocols, SAE Reconciliation Plans, etc.)
• Participate in tracking/monitoring of cases and other vendor or partner deliverables to ensure quality and timeliness of safety management activities, as well as adherence to regulatory and contractual obligations.
• Help in managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
• Support monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
• Maintenance of Arrowhead safety operations documentation (e.g., safety case files), and management of the Safety Mailboxes.
• Help in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements
• Participate in the production and validation of appropriate safety data output from the external or internal safety database for required safety deliverables (e.g. DSUR, IB, ad hoc analyses etc.).
• Manage Arrowhead's QMS for safety/Pharmacovigilance procedures
• Participate in and Help with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities
• Responsible for UAT and Implementation of updates within Safety Database.
• Responsible for Argus console activities like maintaining user sites, groups, accounts, workflow, product, study configurations, and reporting rules.
• Perform periodic MedDRA and WHO Drug upgrades.
• Assist with periodic Disaster recovery and Business continuity tests as needed with Safety Database.
• Support Drug Safety team with listings and data from the Argus database.
• Author and maintain SOPs and WIs for Safety procedures.

Requirements:

• Minimum of BS/BA degree in a health-related area (RN/BSN) and 8 years in the pharmaceutical industry or CRO 
• 5-10 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
• Prior experience in Safety/Pharmacovigilance Operations is required.
• Strong working knowledge of case management and Experience in using ARGUS or other safety databases. Experience with MedDRA/WHO for coding AEs, medical history, and concomitant medications
• Experience with preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketing products (i.e., PSUR/PBRER, PADERs)
• Working experience with Safety Databases (Argus, ArisG or other) is required.
• Knowledge of ICH E2B guidelines in clinical and post-marketing studies.
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively.