Director, Safety Science

The Position

The Director, Safety Science provides leadership to other safety scientists and scientific support in managing the development, implementation and oversight of Arrowhead investigational products.

Responsibilities

• Lead a group of Safety Scientists across Arrowhead’s Therapeutic Areas.
• Supervise the Safety Scientists activities and approve documents and deliverables.
• Train Safety Scientists and contribute to individual scientists projects and goals
• 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

• MD or DO Degree
• 10 + years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
• Prior experience in Safety/Pharmacovigilance Operations
• 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 in Pre marketing and post marketing 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

Preferred

• Experience in data mining, extensive data analyses and oversight of safety science deliverables 

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.