Manager – Drug Safety Operations

Manager – Drug Safety Operations

Requirements

• Minimum of BS/BA degree in a health-related area
• 10 years in the pharmaceutical industry or CRO with at least 6 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience
• 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 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 with quality assurance and compliance for drug safety
• Experience with regulatory inspections, as well as audits of service vendors/business partners would be helpful
• Good organizational skills with the ability to perform multiple tasks efficiently and effectively while mentoring and leading team members
• Proficiency in standard desktop software programs (Word, Excel, Outlook)
• Competency in obtaining, analyzing, and reporting safety data
• Strong oral and written communication skills
• Motivated self-starter who can lead teams and work independently
• Strong interpersonal skills with the ability to professionally interact with all levels of personnel

Responsibilities

• Lead activities related to implementing and maintaining the Safety Database, supporting ARGUS activities, Overseeing the Safety Vendors, and coordinating the Safety Reporting from Clinical Trials and Collaborators.
• Support and/or Lead Safety Operations and ensure flawless execution of Safety and Pharmacovigilance processes
• Vendor management, manage Safety Vendors, CRO and other external parties helping Arrowhead’s drug Safety and Pharmacovigilance.
• 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
• Lead reviewing and monitoring of SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety
• Supervise the development and updating of Clinical Risk Management Plans for all clinical Prepare and update study-specific Safety Monitoring Plans as needed
• Oversee 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 the reconciliation process is occurring for all clinical studies
• Liaise with other company departments including, Clinical Operations, Quality, Regulatory, etc., and provide drug safety support
• Support the Head of Safety in the 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)
• Supervise managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
• Oversee monitoring safety surveillance for Arrowhead’s clinical development products to ensure corporate compliance with national and international adverse event reporting requirements
• Support in quality assurance activities, including deviation reports and generating necessary CAPA to ensure Arrowhead is meeting all safety compliance requirements
• Manage Arrowhead’s QMS for safety/Pharmacovigilance procedures
• Oversee with preparation for regulatory inspections including a compiling of material relating to safety/pharmacovigilance reports and activities

Preferred Qualifications

• Experience with regulatory inspections, as well as audits of service vendors/business partners would be helpful