Senior Director Safety Operations and Compliance (Remote)
The Senior Director of Safety Operations and Compliance will serve as a safety expert accountable for the oversees planning, implementation, and management of Safety Operations and Compliance activities in support of Arcus’s development portfolio, in close collaboration with other Safety and Medical staff. This individual must be able to work effectively in a matrix, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies. This position will report to the Head of Safety.
Responsibilities:
- Responsible for the strategic planning, implementation, and management of Arcus Safety Operations activities.
- Responsible for leading, supporting, and managing the relationships with the safety vendor(s) to ensure effectiveness, quality, and compliance of outsourced activities.
- Ensures timely submission of expedited safety reports to Regulatory Authorities in conjunction with the safety vendor, clinical CROs, and Regulatory Operations.
- Responsible for safety management plans, and associated documents to ensure that study-specific and Regulatory Authority reporting requirements are met and that workflow between CROs, and Arcus are clearly delineated and followed.
- Responsible for the development and maintenance of Safety Data Exchange Agreements with Arcus’ partners and ensures compliance with the agreed upon terms.
- Reviews the safety sections of clinical documents, including the safety reporting section of protocols.
- Responsible for the development, implementation, and maintenance a Safety quality management system including the identification and authoring of required procedural documents to ensure compliance with global regulations
- Responsible for the development of internal and external (with vendors) key performance indicators and metrics to track performance and to be presented at broader Arcus forums.
- Serves as the Safety subject matter expert for internal audits and global inspections. Responsible for identifying and following-up on corrective action plans arising from audits and inspections.
- Responsible for safety inspection readiness activities and preparation and works in collaboration with GCP Quality to align on scheduling of audits for safety vendors.
- Collaborates with Clinical Quality to ensure awareness and training of appropriate Arcus personnel to Safety specific policies and SOPs as appropriate.
- Responsible for hiring and providing managerial support to direct reports with overall responsibility of leading, training, and mentoring for effective performance.
- Effectively collaborates with key stakeholders of cross-functional departments to meet corporate and departmental goals.
Experience:
- Bachelor’s Degree in Health Care of Life Sciences preferred
- Minimum of 10 years’ experience in Pharmacovigilance
- Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams.
- Ability to establish and identify best practices for continuous improvement of case quality, compliance, and process improvement
- Demonstrates the ability to handle increasing responsibilities as scope may change relate to team growth and integration efforts cross-functionally
- Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with cross-functional colleagues
- Ability to work independently, establish priorities, and execute with minimal guidance
- Thorough knowledge and experience in safety reporting in both the clinical trial and post-market settings.
- Strong knowledge and experience with available drug safety database systems, document management systems, and QC tools.
- Extensive experience participating in inspections/audits and leading efforts around related CAPAs.
- Demonstrated ability to work effectively in a dynamic, complex, and fast-paced team environment.
- Expert knowledge of global safety regulations and guidelines.
- Excellent interpersonal, communication, analytical, and organizational skills.
- Strong people and project management experience.
- Experience with auditing/planning audits is preferred.