Senior Medical Director in Safety Science

About the role

The Senior/Executive Medical Director in Safety Science manages a group of medical safety experts providing strategic leadership across our product portfolio and ensuring that patient safety is a priority in pre- and post-marketing drug development activities. This is an influential position responsible for driving innovative medical safety approaches, leading medical safety evaluations, managing safety-related regulatory interactions, and advancing the science of safety prediction and management using cutting-edge methodologies.

Responsibilities

• Lead safety signal prediction, detection, evaluation, and risk management activities
• Ensure medical expertise throughout the product lifecycle with adequate coverage of safety physicians for assigned products
• Cultivate a proactive and predictive approach to theoretical and confirmed safety risks, while maintaining efficient pharmacovigilance monitoring and reporting practices
• Review and assess complex individual case safety reports (ICSRs), with particular focus on serious adverse events
• Provide medical interpretation of safety data and contribute to causality assessments
• Participate in safety governance committees and cross-functional team meetings
• Develop and implement proactive pharmacovigilance strategies for assigned products/therapeutic areas
• Design effective risk management plans and risk minimization measures
• Contribute to benefit-risk assessments and drive data-driven safety decisions
• Collaborate with clinical development teams on protocol safety design and safety monitoring plans
• Implement personal (and group) development plans to build scientific and clinical development experience
• Accountable for the delivery of high quality and timely Safety Science reports
• Author and review aggregate safety reports (PSURs/PBRERs, DSURs, RMPs)
• Represent the company in interactions with regulatory authorities on safety matters
• Contribute to safety-related product labeling and patient information
• Respond to health authority queries related to safety concerns
• Ensure compliance with evolving global pharmacovigilance regulations
• Team Leadership and Development
• Provide medical guidance to Safety Science staff and cross-functional teams
• Mentor junior safety physicians and PV scientists
• Contribute to development of standard operating procedures and work instructions
• Lead continuous improvement initiatives within the PV department
• Collaborate effectively with global affiliates on safety-related activities
• Scientific Advancement
• Maintain awareness of emerging safety methodologies and regulatory requirements
• Represent the company at scientific conferences and industry working groups
• Contribute to publications on product safety profiles and PV science
• Collaborate with epidemiology and real-world evidence teams on safety studies
• Drive innovation in safety signal detection and evaluation approaches

Qualifications

• Hold an MD or equivalent medical qualification (active license to practice preferable but not required)
• 8-10+ years of pharmaceutical industry PV experience
• Experience with regulatory authority interactions
• Leadership experience across different phases of clinical development
• Expert knowledge of global PV regulations and anticipate regulatory trends
• Ability to apply advanced statistical methodologies for safety data analysis
• Familiarity with signal detection algorithms and quantitative PV methods
• Knowledge of benefit-risk assessment frameworks and methodologies, including how to evaluate risk minimization effectiveness
• Advanced Skills:
• Ability to interpret biomarker and genomic data related to safety
• Ability to integrate real-world data into safety assessments
• Ability to translate complex safety concepts for diverse stakeholders
• Ability to visualize complex safety data effectively
• Ability to interpret pharmacoepidemiology studies
• Leadership Capabilities:
• Ability to influence senior management on complex safety matters
• Balance safety considerations with medical need, strategic plans and regulatory expectations
• Strong leadership skills with managerial experience (direct and in a matrix environment)
• Ability to drive innovation in safety signal detection and evaluation approaches