Senior Manager Safety Operations
2 weeks ago
Arrowhead Pharmaceuticals, Inc. is seeking a highly skilled Safety Operations Manager to join our team. As a key member of our Safety Operations department, you will play a critical role in ensuring the safe and effective development of our innovative therapies.
Key Responsibilities- Lead the set-up of new clinical development programs, collaborating with cross-functional teams to ensure seamless execution.
- Oversee safety operation activities with CRO vendors and partners, implementing Arrowhead's safety reporting processes and ensuring compliance with global requirements.
- Monitor compliance with internal standard operating procedures related to drug safety and pharmacovigilance.
- Prepare, support, and track PVAs/SDEAs with partners, ensuring timely and accurate reporting.
- Collaborate with vendors to ensure all internal and external timelines are met, and potential issues are communicated and resolved in a timely manner.
- Support the development and maintenance of departmental SOPs and procedural documents, ensuring compliance with regulatory requirements.
- Participate in inspection-readiness activities, including document and eTMF support, to ensure Arrowhead's safety and pharmacovigilance processes are compliant with regulatory standards.
- Collaborate with Regulatory personnel and CROs to communicate upcoming SAEs requiring expedited submissions to Regulatory Authorities.
- Support the Manager of Safety Operations and Head of Clinical Safety in the review and development of written materials, including clinical trial protocols, informed consent forms, and adverse event reporting forms.
- Minimum of BS/BA degree in a health-related area (RN/BSN) and 5 years in the pharmaceutical industry or CRO with at least 7 years in drug safety operations, pharmacovigilance, and/or a similar combination of education and experience.
- Prior experience in Safety/Pharmacovigilance Operations is required.
- Strong working knowledge of case management and experience in using ARGUS or other safety databases.
- Experience with preparation of 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.
- Good organizational skills with the ability to perform multiple tasks efficiently and effectively.
Arrowhead provides competitive salaries and an excellent benefit package. We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.
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