Senior Medical Director in Safety Science
About The Position
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. This role combines clinical expertise, regulatory acumen, and strategic vision to ensure patient safety while enabling business objectives. The Executive Medical Director is responsible for building, attracting, developing, and retaining an efficient Safety Science team.
Requirements
- 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
- 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)
- Develop safety strategies that balance innovation with compliance
Nice To Haves
- 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
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
- Lead the development of safety sections for regulatory submissions
- 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
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
