The Position

The Clinical Safety Associate, Safety Operations will be responsible for the flawless execution of Safety and Pharmacovigilance operations, implementing Arrowhead’s safety reporting processes and ensuring compliance with FDA, international and global safety reporting requirements for all investigational clinical products, including monitoring and compliance of internal standard operating procedures related to drug safety.

The Associate 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. The Associate will be responsible for clinical safety activities, including, but not limited to: study-start up activities, ensuring the uniform and timely processing of investigational (domestic and foreign) individual case safety reports; ensuring submission of safety reports to regulatory agencies are in compliance with global regulations and Arrowhead standard operating procedures, participation in vendor oversight activities, and assisting in the preparation of safety reports, ad hoc reports, and review and/or authorship of other clinical documentation, as needed. Also, interface and collaborate with Clinical Operations, Quality Assurance, and Regulatory team members and provide safety support during the set-up of new clinical development programs as well as assist in the oversight of local CRO vendors who perform local safety reporting for Arrowhead.

Responsibilities

• Participate in the standardized set-up of new safety projects, including development of Safety plans and documents, and set-up of safety systems
• 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
• 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
• 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

Requirements:

• Bachelor’s degree in a health-related area (RN/BSN) and 5 years in the pharmaceutical industry or CRO with at least 3 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
• Strong working knowledge of FDA and international adverse event reporting regulations (ICH, EMA GPV, GCP etc.) and the ability to interpret and apply applicable regulations
• 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)
• Experience with quality assurance and compliance for drug safety
• Self-motivated and detail oriented. Ability to muti-task and balance day-to-day drug safety operations and project work with tight timelines
• Proficiency in Safety systems, ARGUS, MedDRA coding, standard desktop software programs (Word, Excel, Outlook)
• Competency in obtaining, analyzing, and reporting safety data
• Strong oral and written communication skills
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively while supporting team members
• Motivated self-starter who can support teams and work independently
• Strong interpersonal skills with the ability to professionally interact with all levels of personnel

Preferred:  

• Experience with regulatory inspections, as well as audits of service vendors/business partners would be helpful