Senior Medical Scientist

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;
• Maintain SAE reconciliation with the Arrowhead PV vendor and study CRO to ensure effective reconciliation process;
• Aid in preparation for regulatory inspections including compiling 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.

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
• 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 in preparation with aggregate reports, preferably for investigational drugs (i.e., DSURs, IND Annual reports) or post-marketed products (i.e., PSUR/PBRER, PADERs)
• Strong interpersonal skills with the ability to professionally interact with cross functional team members