The Position

The Senior Medical Scientist, Drug Safety will provide operational and scientific support in managing the development, implementation and oversight of Arrowhead investigational products with engaging in, but not limited to: support safety governance and surveillance procedures including safety reporting processes, advanced safety analytics, expedited and periodic aggregate reports ensuring compliance with internal standard operating procedures, FDA and global safety reporting requirements. They will conduct trend recognition, signal detection, and assist in overseeing relationships with vendors and business partners to ensure the highest quality of safety data is collected, reviewed and analyzed which fulfill all safety reporting requirements are met in the required timelines.

This role will collaborate with Drug Safety Operations, Safety Scientists, medical monitors, clinical operations, QA, Data Management and regulatory colleagues in the set-up of and support of clinical development programs and/or post-marketed products to ensure safety oversight.

This role is base onsite 5x a week at Arrowhead's Research & Development site in San Diego, CA.

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
• Medical Review Responsibilities
• 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

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

Preferred

• Experience in the cardiometabolic and/or rare disease space.

This position may be hired at a lower level depending on the candidate's qualifications, experience, and overall alignment with the needs of the role.

California pay range

$185,000-$210,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.