Clinical Safety Associate, Safety Operations
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes.
The Position
The Clinical Safety Associate, Safety Operations will be responsible for the flawless execution of Safety and Pharmacovigilance operations, implementing Arrowhead’s safety reporting processes and ensuring compliance with FDA, international and global safety reporting requirements for all investigational clinical products.
Responsibilities:
- Participate in the standardized set-up of new safety projects, including development of Safety plans and documents.
- Ensure that reported SAE event reports are received, tracked, evaluated, processed, and distributed/submitted in compliance with regulations.
- Generate appropriate queries to contact drug safety vendors (CROs) to complete and clarify SAE case information as needed.
- Ensure consistency in investigator causality assessment of SAE reports and source documentation for completeness, accuracy, and legibility.
- Support activities related to implementing and maintaining the Safety Database, supporting ARGUS activities.
- Vendor management and coordination of Safety Reporting from Clinical Trials and Collaborators.
- Support reviewing and monitoring of SAE/SUSAR case processing including performing secondary quality review for all case reports.
- Help in compiling safety data required for DSC and DSMB meetings for Arrowhead clinical studies.
- Assist with safety database test configurations.
- Participate in tracking/monitoring of cases and other vendor or partner deliverables.
Requirements:
- Bachelor’s degree in a health-related area (RN/BSN) and 5 years in the pharmaceutical industry or CRO with at least 3 years in drug safety operations.
- Strong working knowledge of FDA and international adverse event reporting regulations.
- Experience with preparation of aggregate reports, preferably for investigational drugs.
- Self-motivated and detail-oriented with strong oral and written communication skills.
Preferred:
- Experience with regulatory inspections and audits of service vendors/business partners.
Salary: $105,000 — $120,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
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