Job
Description
We are looking for a Medical Director, Patient Safety Physician to join our dynamic Research & Development team within Biopharmaceuticals R&D. This role will oversee the Clinical Safety strategy for assigned drug projects and products throughout their development and market lifecycle. You will be responsible for the ongoing evaluation of adverse events and other safety information to effectively manage and predict the safety profiles of compounds in clinical development and marketed products. Key Responsibilities: Safety Surveillance: Lead all safety surveillance activities, including the medical review of individual safety cases, signal detection, and evaluation. Manage Safety Incident Review Committee (SIRC) activities for all products within your area of responsibility. Regulatory Support: Provide medical input for regulatory documentation, including labeling updates. Contribute to the preparation of licensing agreements in your therapeutic area. Stakeholder Engagement: Participate in internal meetings with project teams and external meetings with regulatory bodies, consultants, and licensing partners. Essential Skills and Experience: Medical Degree: MD, MBBS, or equivalent. Clinical Experience: At least 2 years of clinical experience post-registration preferred. Patient Safety Experience: Up to 11-13 years of experience in Patient Safety, including at least 5 years of team management experience. Industry Knowledge: Over 15 years of experience with a comprehensive understanding of the pharmaceutical/biopharmaceutical industry, particularly in clinical research and global regulatory practices governing safety reporting, signal generation, safety evaluation, and risk management. Leadership Skills: Demonstrated commitment to customers and integrity, strategic leadership, decisive action, accountability, collaboration, and team development. Technical Skills: Expertise in drug development, disease and therapeutic area knowledge, pharmacovigilance excellence, and patient benefit-risk assessment. Core Skills: Strong conceptual thinking, influencing ability, initiative, innovation, and business relationship management. Qualifications: Education: Medical degree (e.g., MD, MBBS) required. Experience: Minimum 15 years of total experience with a focus on Patient Safety, including significant experience in leadership and team management.
