Senior Director, Drug Safety Operations

Arrowhead Pharmaceuticals•San Diego, CA

32d•$280,000 - $300,000

About The Position

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Senior Director, Drug Safety Operations will be provide leadership and direction to the Drug Safety operations for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance, vendor oversight activities and ensures compliance and operational excellence for PV related activities. The Senior Director, Drug Safety Operations will also support in 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 clinical programs.

Requirements

12+ years of experience in Drug Safety/Pharmacovigilance Operations
Bachelor of Science with an advanced degree in 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 leadership and organizational skills with the ability to perform multiple tasks efficiently and effectively.

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 corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs.
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.
Oversee submission activities for ICSRs and aggregate reports.
Collaborate with vendors for TMF Safety documents filing and review.
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.
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
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 Head of Clinical Safety & Pharmacovigilance 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 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.
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.).
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.
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.