Senior Medical Scientist

Arrowhead Pharmaceuticals•San Diego, CA

24d•$185,000 - $210,000•Onsite

About The Position

Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing medicines for intractable diseases by silencing the genes that cause them. They utilize a broad portfolio of RNA chemistries and efficient delivery modes to trigger RNA interference, leading to rapid, deep, and durable gene knockdown. Their therapies leverage the natural RNAi pathway for gene silencing. Arrowhead focuses on diseases with a genetic basis, often characterized by overproduction of disease-involved proteins. Their versatile RNAi technologies allow them to target conditions in virtually any therapeutic area, including those not addressable by small molecules and biologics. They are leaders in applying RNAi outside the liver, with a pipeline including liver and lung targets and preclinical candidates. Arrowhead's headquarters are in Pasadena, CA, with R&D teams in Madison, WI & San Diego, CA, and a manufacturing facility in Verona, WI. The company values nimble, science-driven innovators collaborating to bring new therapies to patients. The Senior Medical Scientist, Drug Safety will provide operational and scientific support for the development, implementation, and oversight of Arrowhead's investigational products. This includes supporting safety governance and surveillance procedures, safety reporting processes, advanced safety analytics, and expedited and periodic aggregate reports, ensuring compliance with internal SOPs, FDA, and global safety reporting requirements. The role involves trend recognition, signal detection, and overseeing vendor and business partner relationships to ensure high-quality safety data collection, review, and analysis within required timelines. The position collaborates with Drug Safety Operations, Safety Scientists, medical monitors, clinical operations, QA, Data Management, and regulatory colleagues to ensure safety oversight for clinical development programs and/or post-marketed products. This role is based onsite five days a week at Arrowhead’s Research & Development site in San Diego, CA.

Requirements

MD or DO Degree
8 years in the pharmaceutical industry or CRO
5 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
Experience in Signal Detection and Safety Data Analytics
Strong safety science experience to utilize data analysis and visualization platforms and tools by applying advanced scientific algorithms and methods and translating the strategic vision of safety science into risk mitigation strategies and data visualization insights
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 ARGUS case management and medical review processing; experience in using ARGUS or other safety databases; experience with MedDRA/WHODrug for coding AEs, medical history, and concomitant medications, post marketed and premarketed products
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)
Strong interpersonal skills with the ability to professionally interact with cross functional team members

Nice To Haves

Experience in the cardiometabolic and/or rare disease space.

Responsibilities

Review potential safety observations, safety signals and contribute to the Safety Review Committee and Safety Governance process through the preparation and presentation of safety data; prepare and assess safety data for ongoing periodic, aggregate safety data reviews, and provide recommendations for review and approval by the Executive Safety Committee
Prepare periodic aggregate safety reports including PSUR, DSUR, FDA IND Annual Report etc.
Performs routine signal detection, identifies and evaluate safety signals
Continually stay up to date on relevant regulations associated with the above activities
Develop and update of Safety Surveillance Plans for assigned products
Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports, Company Core Data Sheet, Investigators Brochure and Risk Management Plan
Assist in quality assurance activities, including deviation reports
Monitor SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure effective reconciliation process
Assist with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities
Support activities associated with launching a filing for the BLA/NDA or global marketing
Perform Medical Review on SAE/SUSAR if applicable
Conduct active case follow-up, including written and verbal follow-up with clinical operations, clinical investigators and sites if applicable