Manager, Drug Safety Operations - Arrowhead Pharmaceuticals
San Diego, CA
About the Job
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. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Manager will interface and collaborate with cross-department members to provide safety operations support during the set-up of new clinical development programs. The Manager will be responsible for oversight of safety operation activities with Arrowhead CRO vendors and partners, implementing Arrowhead safety reporting processes ensuring compliance with global requirements and monitor compliance of internal standard operating procedures related to drug safety & pharmacovigilance.
Responsibilities
- Prepare, support and track PVAs/SDEAs with partners
- Monitor compliance with partner Safety related activities needed as per PVA/SDEA
- Create and maintain Safety Management Plans and Reporting documents in collaboration with vendors
- Review vendor scope and assist with study level budgets as needed
- Provide vendor oversight, including tracking KPI's and collaborate with multiple vendors for process setup & improvements
- Perform and manage SAE reconciliation between databases
- Responsible for data clean-up and data migration from vendor Safety database
- Oversee submission activities for ICSRs and aggregate reports
- Collaborate with vendors for TMF Safety documents filing and review
- Manage day to day operation of Safety database
- Responsible for UAT and Implementation of updates within Safety Database
- Responsible for Argus console activities like maintaining user sites, groups, accounts, workflow, product, study configurations, and reporting rules
- Perform periodic MedDRA and WHO Drug upgrades
- Assist with periodic Disaster recovery and Business continuity tests as needed with Safety Database
- Support Drug Safety team with listings and data from the Argus database
- Author and maintain SOPs and Wis for Safety procedures
Requirements:
- Minimum of Bachelor's degree in Life Sciences, Healthcare, or relevant field/ equivalent qualification with 8 years of experience working in Drug Safety/Pharmacovigilance Operations
- Prior experience in Pre-marketing Drug Safety/Pharmacovigilance Operations
- Working experience with Safety Databases (Argus, ArisG or other)
- Knowledge of ICH E2B guidelines in clinical and post-marketing studies
- Good organizational skills with the ability to perform multiple tasks efficiently and effectively
- Experience with standard desktop software programs (Word, Excel, PowerPoint, Outlook)
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.