Manager, Drug Safety Operations

Compensation Description

The base salary range for this position in the selected city is $120,000 - $180,000 annually.

Position Description

The Manager will be responsible for assist in implementing Arrowhead safety reporting processes ensuring compliance with FDA, international and global safety reporting requirements for all investigational clinical products, including monitoring and compliance of internal standard operating procedures related to drug safety. He/she will assist in preparation and review of regulatory reports such as serious unexpected serious adverse reactions (SUSARs) and periodic aggregate reports in compliance with FDA, EMA and other international guidelines and regulations for the clinical programs. The Manager will interface and collaborate with Clinical Operations, Quality Assurance, and Regulatory team members and provide safety support during the set-up of new clinical development programs as well as assist in the oversight of local CRO vendors who perform local safety reporting for Arrowhead.

Responsibilities

• Assist in implementing and maintaining the Comprehend system (clinical analytics system)
• Help review and monitor SAE/SUSAR case processing including, performing the secondary quality review for all case reports in the safety database
• Assist in developing and updating of Clinical Risk Management Plans for all clinical studies. Prepare and update study-specific Safety Monitoring Plans 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
• 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 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
• Assist 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)
• Assist in managing and updating safety surveillance procedures including signal detection review processes and monitoring abnormal trending of adverse events and laboratory results
• Assist in the monitoring 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 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

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
• 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 processing. 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
• 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 work independently
• Strong interpersonal skills with the ability to professionally interact with all levels of personne