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’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 requirements based on audit/inspection findings, as needed.
Conduct routine, formal audits of internal processes, procedures and systems to ensure ongoing compliance and readiness for external inspections/audits.
Work in close conjunction with Clinical QA to develop and execute appropriate audit plans for assessing global partners, safety vendors/CROs, or other third parties in conjunction with associated global pharmacovigilance agreements, safety data exchange agreements or master service agreements/contracts.
Additional Safety / Departmental Management Responsibilities
Assist DS Operations in performing Quality Control reviews of all incoming cases to ensure the accuracy, integrity and completeness of information entered in the safety database.
Monitor industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and provides direction for developing and/or revising departmental controlled documents and changes/updates to safety systems.
Lead the department’s activities around the creation, review and revisions to all controlled documents and procedures, in close consultation with subject matter experts.
Ensure departmental controlled documents are reviewed on a routine basis, in compliance with company review policies.
Supports departmental document retention requirements.
Maintain the Pharmacovigilance Master File for Onyx, in accordance with EMA regulations and guidelines.
Prepare/Review appropriate documentation in response to safety-related questions raised by Regulatory Authorities or external Partners, in collaboration with PVG & RMP or DS Operations, as needed.
Collaborate with internal contributors in Regulatory, Clinical QA, Clinical Development, legal and other cross-functional areas to support safety reporting and analysis processes and communications.
Collaborate with pharmacovigilance and drug safety colleagues within global Partners.
Manage the process for identifying, evaluating, and selecting outsourcing vendors (e.g., CROs, Call Centers, safety database vendors).
Participate in due diligence teams to evaluate new potential in-licensing and out-licensing opportunities, as required.
Assist departmental management in developing and monitoring appropriate metrics to effectively manage utilization of departmental personnel, ensuring planned activities are adequately resourced, agreed upon timelines are met, and that colleagues are fully engaged in supporting the business.
Assist in the development and tracking of departmental goals and objectives .
Participate in the development and management of departmental budget.
Ensure that new hires are suitably qualified and that personnel are developed to ensure that their drug safety skills are in line with the business need, and that staff have a strong awareness and understanding of the appropriate worldwide safety regulations.
Contact immediately the Head of Drug Safety if a regulatory agency has requested an inspection, or if there are any serious compliance observations within the Drug Safety department.
Other duties as assigned
Management of Direct Reports
Mentor, train and supervise staff at a functional level.
Ensure each new direct report is on-boarded and trained per Onyx and departmental guidelines and SOPs
Review and authorize activities to assess the workload of direct reports.
Identify any performance issues and ensure an appropriate and timely performance improvement plan is undertaken.
Identify training needs of direct reports and develop training plans to address those needs.
Minimum of 8 years of industry experience in one of more of the following areas: Drug Safety Operations, Pharmacovigilance, Risk Management Planning, Epidemiology, Clinical Development and/or Quality Assurance. 2-3 years of direct experience in Drug Safety Compliance or Risk Management required.
Both pre-approval and post-marketing experience in a global environment required.
Minimum of 2 years supervisory experience required
Oncology experience highly desired.
Management of Staff:
Develops direct reports to expand employee performance levels and assure retention of high performing Onyx employees.
Functional/Technical Knowledge & Skills:
Expert knowledge of relevant ICH, US and EU regulations and requirements for pharmacovigilance in both clinical trial and post-marketing safety environments.
Extensive knowledge of medical terminology and principles of clinical assessment of adverse events in the pharmaceutical industry.
Expertise in MedDRA dictionary with relevance to adverse event coding.
Experience in working with software based drug safety systems, preferably the ARISg safety system.
Strong computer skills (MS Office).
Customer & Industry Knowledge:
Advanced knowledge of domestic and international safety regulations, Good Clinical Practices, principles of drug development and safety assessment of marketed and investigational drugs.
Bachelor’s (BS/BA), Masters or PharmD degree in life sciences, pharmacy, nursing or RN.
Outstanding communication skills (verbal and written), including formal presentation skills.
Strong leadership and team management skills
Demonstrated decision-making, organizational, prioritization and problem-solving skills.
Focus on detail with enthusiasm to constantly seek ways to improve processes and practice.
Strong analytical and assessment skills
Advanced analytical skills, strategic thinking, organizational leadership, and results-oriented performance.
Outstanding interpersonal skills and professionalism
Ability to work in a dynamic environment and manage competing priorities.
Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds, and provide appropriate feedback to colleagues and management.
Proven experience in group facilitation; ability to drive teams to make decisions and achieve deliverables within agreed parameters and timelines.
Ability to work independently, take initiative and complete tasks per deadlines.
Ability to travel both domestically and internationally (< 20%)
Problem Solving – Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; looks beyond the obvious and doesn’t stop at the first answers.
Priority Setting – Spends his/her time and the time of others on what’s important; quickly zeros in in the critical few and puts the trivial many aside; eliminates roadblocks; creates focus.
Perspective – Looks toward the broadest possible view of an issue/challenge; has broad-ranging personal and business interests and pursuits; can easily pose future scenarios; can think globally; can discuss multiple aspects and impacts of issues and project them into the future.
Informing – Provides the information people need to know to do their jobs and to feel good about being a member of the team, unit, and/or the organization; is timely with information; provides individuals information so that they can make accurate decisions.
Managerial Courage – Doesn’t hold back anything that needs to be said; provides current, direct, complete, and actionable positive and corrective feedback to others; lets people know where they stand; faces up to people problems on any person or situation quickly and directly; is not afraid to take negative action when necessary.
Integrity and Trust – Is widely trusted; is seen as a direct, truthful individual; can present the unvarnished truth in an appropriate and helpful manner.