Manager, Drug Safety Operations
Company: Arrowhead Pharmaceuticals, Inc
Location: Pasadena
Posted on: March 20, 2023
Job Description:
Compensation DescriptionThe base salary range for this position
in the selected city is $120,000 - $180,000 annually.Position
DescriptionThe 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 activitiesRequirements:
- 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
Keywords: Arrowhead Pharmaceuticals, Inc, Pasadena , Manager, Drug Safety Operations, Executive , Pasadena, California
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