Director, Global Patient Safety Sciences Delivery – General Medicine

• Serve as the first point of contact for General Medicine operations, including safety data processing, submission creation and documentation


• Ensure completeness, accuracy and timeliness of safety operations


• Execute safety surveillance, signal management and aggregate reporting activities across the portfolio


• Develop common practices, processes and templates to standardize core activities across products and therapeutic areas


• Ensure compliance and quality management of Safety Sciences Delivery activities, regulations, SOPs and monitoring tools


• Lead signal detection coordination and signal management across General Medicine, including SMT, SSP and SER


• Develop innovative approaches integrating new technologies


• Analyze aggregate safety data to identify emerging safety issues and patterns


• Coordinate cross-functional delivery of benefit-risk assessments for periodic safety reports, including DSURs and PSURs


• Support GPS portfolio documents such as ARM, RMP and SMP with Medical and Safety perspectives


• Develop and implement training programs, standardized curriculum, proficiency matrix and knowledge repository


• Liaise with Safety Sciences Strategy General Medicine GPS Leads


• Collaborate with Clinical, Regulatory, Medical Affairs, Biostatistics and Data Management interfaces


• Build, coach and scale a high-performing team


• Drive succession planning and talent pipelines


• Implement talent strategy and leadership development initiatives


• Report to the ED, Global Patient Safety Sciences Delivery

Requirements

• Advanced Degree required in life sciences or healthcare


• 12+ years of PV experience


• Preferably experience focused on Safety Sciences and General Medicine


• Strong attention to detail


• Ability to assess and optimize Safety operations processes


• Ability to drive consistency and ensure high-quality, compliant execution


• Strong leadership capabilities and presence


• Strong interpersonal, verbal and written communication skills


• Organizational and workload planning skills


• Ability to manage multiple different projects simultaneously


• Preferred experience with oversight of operations within a global patient safety organization


• Preferred experience with AI technologies


• Preferred experience leading a matrixed role across multiple organizational areas


• Preferred people management experience


• 25% travel may be required

Core Competencies

Demonstrates expertise in safety data processing, signal management, and compliance within General Medicine. Proven ability to lead cross-functional teams, develop training programs, and implement innovative approaches to enhance safety operations.

Highest-signal resume keywords

• Safety Data Processing


• Signal Management


• Aggregate Reporting


• Leadership Capabilities


• Advanced Degree in Life Sciences

Hard Skills

• Safety Operations


• Compliance Management


• Data Analysis


• Benefit-Risk Assessment


• Process Standardization


• Safety Surveillance


• Signal Detection


• Project Management


• Training Program Development


• Quality Management

Soft Skills

• Attention to Detail


• Interpersonal Communication


• Organizational Skills


• Workload Planning


• Leadership Presence

Industry Keywords

• Pharmacovigilance


• General Medicine


• Safety Sciences


• Global Patient Safety


• Regulatory Compliance

Tools & Technologies

• Monitoring Tools


• AI Technologies