Drug Safety Scientist

Full Time On-Site/Hybrid Clinical Research Drug Safety Apply for this Job 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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Drug Safety Scientist 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. The Safety Scientist 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. The Safety Scientist will collaborate with medical monitors, clinical operations, QA and regulatory colleagues in the set-up of and support of new clinical development programs to ensure the preparation of safety documents and data. These collaborative efforts will continue throughout the duration of the clinical program supporting Data Monitor Committee activities, Risk Assessments, Investigator Brochure, protocol and Informed Consent reviews. The Safety Scientist will assist in the development, implementation and monitoring of safety policies/standard operating procedures.

Responsibilities

• Monitor Safety activities and active membership in TST (Trial Safety Team), PST (Program Safety Team) or other Safety Governance activities.
• Review potential safety observations, safety signals and contribute to the 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 DSUR, FDA IND Annual Report etc.
• Performs routine signal detection, trend recognition in blinded and unblinded patterns for clinical trials and contribute to signal detection from the internal safety database and literature reports
• Identifies and evaluates safety signals through assessment of individual case safety reports and aggregate data
• Able to give presentations of safety data to intradepartmental and interdepartmental audiences
• Lead and facilitate department meetings; prepare agendas and meeting minutes; assist with vendor management and oversight
• Vendor management, budget review and CRO project coordination
• Keeping updated on relevant regulations associated with the above activities
• Collaborate with cross-functional team members across the matrix
• Oversee CRO vendors who perform local safety reporting for Arrowhead
• Develop and update of Clinical Risk Management Plans for clinical studies he/she will be responsible for
• Review and monitor SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety database for the responsible Arrowhead programs
• Supports the preparation and maintenance of safety sections of the Clinical Protocols, Clinical Study Reports the Company Core Data Sheet and Risk Management Plan
• Prepare and update study-specific Safety Monitoring Plans and study reporting matrix as needed
• 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 for various Arrowhead programs
• Assist 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 effective reconciliation process
• Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety support
• 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)
• Manage and update safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
• Monitor safety surveillance for Arrowhead's clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
• Assist in quality assurance activities, including deviation reports and generating necessary
• Generate safety queries as needed for clarification of clinical reports
• Conduct active case follow-up, including written and verbal follow-up with clinical operations, clinical investigators and sites
• CAPA to ensure Arrowhead is meeting all safety compliance requirements
• Manage Arrowhead's QMS for safety/Pharmacovigilance procedures
• 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
• Contribute to on-going process enhancement for Arrowhead’s Safety Management Plans, Benefit Risk strategies, including developing standard procedures, work instructions and templates

Requirements:

• Minimum of BS/BA degree in a health-related area and 5 - 8 years in the pharmaceutical industry or CRO with at least 5 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
• Experience in Signal Detection and Safety Data Analytics is critical
• 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 processing; experience in using ARGUS or other safety databases; experience with MedDRA/WHODrug 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 in clinical trial activities, SMP development, protocol review and other Arrowhead clinical and safety documents
• Expertise in Integrated Safety Summary reviews, regulatory submissions, protocol, ICF, and other documents
• Experience with regulatory inspections and audits of service vendors/business partners would be helpful
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively
• Proficiency in standard desktop software programs (Word, Excel, Outlook)
• Competency in presenting data, obtaining, analyzing, and reporting safety data
• Motivated self-starter who can work independently, adapt to work environment, team, timelines and deliverables
• Strong interpersonal skills with the ability to professionally interact with cross functional team members
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Track record in monitoring awareness dates, day zero and due dates for regulatory submissions in collaboration with the regulatory documents

California pay range

$170,000—$210,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.