Associate Director, Drug Safety Operations

Arrowhead Pharmaceuticals is seeking an Associate Director, Drug Safety Operations to maintain its safety database, support vendor oversight activities, and ensure compliance and operational aspects of PV related activities.

Requirements

• 10 years of experience in Drug Safety/Pharmacovigilance Operations
• Bachelor of Science/4-year degree in Biological or Life Sciences, pharmacy, nursing or related healthcare field.
• 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)
• Working experience with Safety Databases (Argus, ArisG or other) is required.
• Knowledge of ICH E2B guidelines in clinical and post-marketing studies.

Benefits

• Competitive salaries
• Excellent benefit package
• Generous Paid Time Off
• 401k Matching
• Retirement Plan