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Job Field: Security
Location: South San Francisco, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Associate Director, Drug Safety Compliance & TrainingDrug Safety | South San Francisco, CA, United StatesSummary:The Associate Director, Safety Compliance and Training has responsibility for monitoring, investigating and assessing Drug Safety and Pharmacovigilance processes for consistency and compliance with global laws, regulatory requirements and internal standards. Leads the development and maintenance of a comprehensive training and education program to ensure adequate training of all internal and external parties in safety management processes and policies. Leads safety audit/inspection activities in close conjunction with Clinical Quality Assurance. Liaises with departmental management and cross-functional teams throughout the organization to optimize departmental quality, compliance, and utilization, and to investigate and recommend opportunities for improvement. This role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues from, Regulatory, QA, IT, Clinical Development, Medical and Scientific Affairs, Commercial, and Legal.Essential/Primary Duties, Functions and Responsibilities:Compliance Monitoring and Investigation Responsibilities* Create, implement and maintain a comprehensive safety metrics program, in conjunction with Drug Safety (DS) and Pharmacovigilance & Risk Management (PVG & RM) subject matter experts, to monitor compliance, timeliness, data quality, and adherence to regulatory guidelines, contractual agreements with global partners, and internal policies and procedures. * Assesses trends, opportunities for process improvements, and remediation, including revisions to controlled documents, training issues/opportunities, or individual performance issues.* Work with DS Operations to assess current processes and submission compliance metrics to business partners, third parties, internal stakeholders, and regulatory authorities to identify root causes for late submissions and other opportunities for improvement.* Work with PVG & RM colleagues regarding opportunities to improve aggregate safety reporting compliance and quality for PSURs, DSURs, REMS, and RMPs, as needed* Work with Medical Directors regarding opportunities to improve signal detection and evaluation processes, as needed.* Prepare routine status reports for departmental Management on above metrics and compliance programs.* Determines unmet needs and resolves issues with departmental Managers/staff, as needed.Safety Training Responsibilities* Responsible for all safety-related training on drug safety principles, policies and SOPs within Onyx including all new departmental hires, routine training for all DS colleagues, training of all new company personnel, and all external training including sales and marketing, legal and external vendors (CROs/Call Centers), and Investigators/clinical study site staff, as appropriate.* Coordinates development of appropriate training materials and delivers necessary training programs/presentations, in conjunction with appropriate internal and external subject matter experts, as appropriate. * In conjunction with departmental Managers, develop and maintain functional-level training matrices for all positions within the department. Assist Managers in monitoring adherence to training requirements and appropriate documentation in individual&rsquo;s training records.Audit and Inspection Support* Act as departmental lead for audit/inspection activities, in close association with Clinical Quality Assurance (QA) group.* Provide preliminary audit/inspection preparation, internal host support and document/interviewee facilitation, and document management/oversight for DS, as needed.* Develop and recommend appropriate corrective actions related to audit/inspection findings.* Lead follow-up activity regarding audit/inspection commitments to ensure documentation is adequate and associated timelines are met.* Supports updates to departmental controlled documents and training requi

KEY REQUIREMENTS:

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Not stated