The Position
The Associate Director, Drug Safety Operations will be responsible for maintaining Arrowhead's safety database, supporting vendor oversight activities, ensuring compliance and operational aspects of PV related activities. The Associate Director, Drug Safety Operations will also support in preparation and review of regulatory reports such as periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for clinical programs.
Responsibilities
• Support 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. • Partner with clinical and safety teams to support consistent, accurate, and regulatory-compliant assessment and documentation of SAEs and events of special interest (e.g., pregnancy, overdose) across clinical programs. • Collaborate with cross-functional stakeholders to support standardized safety set-up for new clinical studies, including contribution to Safety Management Plans, Safety Monitoring Plans, Clinical Risk Management Plans, and safety system configurations. • Work closely with CROs and PV vendors to provide oversight of safety case management activities, including quality review processes and monitoring of expedited and aggregate reporting timelines. • Partner with Finance, Clinical Operations, and vendors to provide oversight of safety budgets and financial activities, including scope alignment, forecasting, invoice review, and cost tracking. • Collaborate with internal teams and external partners to manage Pharmacovigilance Agreements (PVAs), SDEAs, and vendor contracts, supporting compliance with regulatory, contractual, quality, and financial requirements. • Engage with safety vendors and CROs to monitor deliverables, support reconciliation processes, maintain TMF/eTMF safety documentation, and promote continuous improvement. • Coordinate with Clinical Operations, CROs, and PV vendors to support and oversee Clinical-Safety Database reconciliation activities, ensuring timely, accurate, and well-documented reconciliation across studies. • Work in partnership with Safety Science and Medical teams to support safety surveillance activities, including signal detection, trend analysis, similar-event evaluations, and review of abnormal laboratory data. • Collaborate with Regulatory Affairs and study teams to support safety reporting activities across clinical trials, including preparation for expedited reporting and health authority communications. • Partner with safety systems and vendor teams to support oversight of the Safety Database (e.g., Argus), including UAT, system updates, data outputs for DSURs, IBs, DSMB/DSC materials, and business continuity activities. • Support inspection readiness and regulatory inspection activities by collaborating on document preparation, reconciliation support, inspection responses, and participation in health authority inspections as needed. • Contribute to the authoring, review, and maintenance of SOPs, work instructions, and cross-functional documents, while supporting team development and the Head of Clinical Safety & Pharmacovigilance in governance activities. • 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. • 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. • Review and monitor SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety. • Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure the reconciliation process is occurring for all clinical studies. • Support monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting 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.). • 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.
Requirements
10 years of experience in Drug Safety/Pharmacovigilance Operations Bachelor of Science/4-year degree in Biological or Life Sciences, pharmacy, nursing or related healthcare field. Strong working knowledge of case management and processing. 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. Preferred: HCP experience