Medical Director, Drug Safety and Pharmacovigilance

Role Summary

Medical Director, Drug Safety and Pharmacovigilance responsible for ensuring the safety of investigational products, leading safety reviews, and contributing to regulatory safety deliverables. Works independently on safety activities and collaborates cross-functionally to maintain safety science standards and regulatory compliance. Remote work is acceptable.

Responsibilities

• Serve as the safety physician lead for designated product.
• Conduct medical review of individual case safety reports (ICSRs), including seriousness, expectedness, and causality assessment, with proper coding and global regulatory compliance.
• Perform aggregate data analysis and interpretation.
• Author and provide medical input to safety-related regulatory documents (e.g., DSURs, ASRs, PSURs, PADERs) or other deliverables.
• Lead or contribute to safety review committee activities, including data analyses, signal detection and evaluation, interpretation of safety signals and trends, and communication of safety assessments.
• Contribute to clinical and regulatory documents (study protocols, investigator brochures, statistical analysis plan, clinical study reports).
• Collaborate with clinical development, data management, regulatory affairs, biostatistics, and medical affairs on safety issues.
• Review and summarize relevant scientific literature to support safety evaluations and regulatory submissions.
• Support senior medical leadership on complex pharmacovigilance tasks such as integrated safety analyses and risk management strategies.
• Support pharmacovigilance audits and regulatory inspections.
• Ensure high-quality case processing, database oversight, and safety deliverables in collaboration with pharmacovigilance teams.
• Stay current with global pharmacovigilance regulations and best practices.
• Additional tasks as needed.

Qualifications

• MD, DO, or U.S. equivalent; at least 3 years of industry pharmacovigilance experience as a safety physician.
• Experience in neurology, immunology, and rare diseases preferred.
• Experience in early and late-stage clinical trials preferred.
• Strong pharmacovigilance with signal management skills.
• Ability to lead and conduct individual safety case report processing, including triage, medical review, and safety data analysis.
• Knowledge of international safety reporting requirements and signal detection.
• Knowledge of pre- and post-marketing drug safety standards.
• Proficiency with safety databases (Argus preferred) and coding dictionaries (MedDRA, WHODRUG).
• Excellent problem-solving, analytical, and communication skills (oral and written).
• Ability to work effectively in a collaborative team and build cross-functional relationships.
• Ability to meet multiple deadlines in a fast-paced environment, with high accuracy.
• Ability to prioritize and work remotely with minimal supervision.
• Leadership and independent contribution abilities; strong ethics and scientific integrity.

Skills

• Safety physician leadership
• Medical review of ICSR, seriousness, causality assessment
• Aggregate data analysis and interpretation
• Regulatory writing (DSURs, PSURs, PADERs, etc.)
• Safety signal detection and evaluation
• Study protocols, investigator brochures, SAP, clinical study reports
• Cross-functional collaboration (clinical development, regulatory, biostatistics, data management, medical affairs)
• Literature surveillance for safety evaluations
• Integrated safety analyses and risk management strategies
• Audits and inspections readiness

Education

• MD, DO, or U.S. equivalent

Additional Requirements

• Ability to work remotely