Associate Director - Safety Management

Role Summary

Associate Director - Safety Management: Provide technical leadership to the Safety Management organization, including strategic direction, project leadership, and standardization. Serve as the subject matter expert on inputs, outputs, reporting, and oversight of safety management processes.

Responsibilities

• Responsible for alignment of strategy and design of the processes and procedures for safety operations.
• Influence complex regulatory, business or technical issues within a business area and/or function.
• Own and provide expertise of processes across Safety Management.
• Provide consultation to safety management and operations worldwide.
• Provide training, on-boarding, and mentoring to individuals within and outside the Safety Management group.
• Lead projects to simplify and improve work.
• Collaborate cross-functionally to ensure alignment of goals and deliverables.
• Provide responses to regulatory inquiries.
• Serve as the primary functional interface for Safety Management in issue resolution.
• Incorporate industry-leading innovative initiatives to improve safety activities.
• Provide SME on regulation changes through gap assessments and control measures implementation.
• Lead or participate in high-priority, cross-functional projects and make decisions impacting the function or geography.
• Share product/therapeutic area expertise.

Quality

• Develop, implement, and follow internal procedures to ensure compliance and quality of safety operations processes.
• Lead during audits and inspections to ensure accurate information is provided as needed.
• Maintain audit and inspection readiness through proactive preparedness activities.

Automation, Data Systems and Analytics

• Support automation of data intake from cross-functional platforms into systems owned by GPS.
• Understand interfaces between GPS systems, cross-functional platforms, and regulatory data.
• Support configuration and problem resolution of systems and processes related to expedited reporting.

External Collaboration

• Lead external collaborations (e.g., reviewing agreements, data migrations).
• Monitor vendor performance in relation to contracts, regulations, and procedures.
• Provide input into financial planning for budgeting and cost analysis for sourcing arrangements.
• Review and consult on Business License Agreements/Alliances.
• Support migration activities to maintain compliance and proper data migration.
• Attend Safety Board and/or Safety Team meetings as needed.

Other

• Understand roles and responsibilities of the EU QPPV.

Qualifications

• Bachelor‚Äôs degree in healthcare-related field or life sciences or demonstrated equivalent experience (PharmD, BSN, MSN preferred).
• 3+ years of experience in safety management.
• Proven expertise in Pharmacovigilance.
• Clinical knowledge of disease states, physiology, and pharmacology.
• Knowledge of global regulations (FDA, EMA GVP) for adverse event and device incident reporting.
• Knowledge of Global Patient Safety policies and procedures.

Other Information

• Experience authoring/interpreting SOPs and delivering training.
• Project management skills.
• Ability to manage multiple tasks, attention to detail, and organizational skills.
• Coaching/mentoring skills; leadership by influence; ability to negotiate across teams.
• Fluent English; strong written and verbal communication.
• Basic computer skills (Word, Excel, Windows).
• Role based in Indianapolis, IN with relocation provided.