Manager, Drug Safety Operations

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 Manager of Safety Operations will be responsible for the flawless execution of Safety and Pharmacovigilance operations, reporting to and assisting the VP/Head of Drug Safety and Pharmacovigilance in 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. He/she 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 manager will 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

• Lead 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 and/or Lead Safety Operations 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.
• Provide drug safety case management support to medical monitors; assist in following up on queries for case reports, abnormal laboratory values, or any other relevant safety and medical data
• Lead reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety
• Supervise the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed
• Oversee 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 support
• Support the Head of 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)
• Supervise managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
• Oversee monitoring safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
• Support in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements
• Manage Arrowhead's QMS for safety/Pharmacovigilance procedures
• Oversee with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities

Requirements:

• Minimum of BS/BA degree in a health-related area
• 10 years in the pharmaceutical industry or CRO with at least 6 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
• Experience with regulatory inspections, as well as audits of service vendors/business partners would be helpful
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively while mentoring and leading team members
• Proficiency in standard desktop software programs (Word, Excel, Outlook)
• Competency in obtaining, analyzing, and reporting safety data
• Strong oral and written communication skills
• Motivated self-starter who can lead teams and work independently
• Strong interpersonal skills with the ability to professionally interact with all levels of personnel

California pay range

$115,000—$135,000 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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