Medical Director Safety Science - Remote

Overview

The Medical Director of Safety Science serves as a key medical expert for our safety surveillance activities, providing medical leadership for assigned products within our portfolio. You will implement pharmacovigilance (PV) strategies, conduct medical safety evaluations, support safety-related regulatory activities, and contribute to the advancement of safety monitoring practices. This role combines clinical expertise with regulatory knowledge to ensure patient safety while supporting business objectives.

In Short

• Serve as a safety physician for assigned products.
• Conduct safety signal detection, evaluation, and assessment activities.
• Review and evaluate individual case safety reports (ICSRs).
• Provide medical interpretation of safety data.
• Participate in safety review committees.
• Implement pharmacovigilance strategies.
• Support the development of risk management plans.
• Contribute to benefit-risk assessments.
• Work with clinical teams on safety monitoring.
• Support the preparation of safety sections for regulatory submissions.

Requirements

• MD or equivalent medical qualification.
• 5-8 years of pharmaceutical industry PV experience.
• Exposure to regulatory authority interactions.
• Strong knowledge of global PV regulations.
• Ability to apply statistical methods for safety data interpretation.
• Understanding of signal detection processes.
• Knowledge of benefit-risk assessment principles.
• Ability to communicate effectively with management.
• Experience supporting product safety activities.
• Commitment to developing safety science expertise.

Benefits

• Opportunity to lead safety surveillance activities.
• Collaborative work environment.
• Professional development opportunities.
• Contribute to innovative safety assessment approaches.
• Work with cross-functional teams.