Senior Director, Drug Safety Operations
Company: Arrowhead Pharmaceuticals
Location: San Diego
Posted on: February 18, 2026
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Job Description:
Job Description Job Description 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.
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. 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. California pay range $280,000—$300,000 USD Arrowhead
provides competitive salaries and an excellent benefit package. All
applicants must have authorization to work in the US for a company.
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Keywords: Arrowhead Pharmaceuticals, Coachella , Senior Director, Drug Safety Operations, Science, Research & Development , San Diego, California
