Medical Director

Are you a Medical Doctor passionate about patient health and safety? An exciting opportunity exists for experienced Patient Safety Physicians to contribute to the oversight of drug safety across multiple therapeutic areas. The role involves working on products in late-stage clinical development or post-marketing, with a focus on cardiovascular, renal, hepatic, and metabolic conditions.

This position allows you to make a tangible impact on patient safety while working collaboratively with multidisciplinary teams.

As a (Senior) Patient Safety Physician, you will lead or contribute to integrated patient safety and pharmacovigilance activities for compounds in development or already on the market.

Responsibilities include:

• Designing and implementing strategies to generate robust safety evidence
• Developing patient-centric risk minimization and benefit-risk strategies for assigned compounds
• Planning, managing, and monitoring pharmacovigilance activities for assigned drugs, including:
• Setting up safety analyses in clinical and safety databases
• Continuously monitoring and updating product safety and benefit-risk profiles
• Identifying, evaluating, and managing safety signals
• Collaborating with clinical development, medical, and epidemiology teams to assess and communicate patient-centric benefit-risk profiles
• Interpreting safety data for clinical study reports and regulatory submissions
• Reviewing and providing medical-scientific input for regulatory safety documents (e.g., investigator materials, periodic safety reports, risk management plans, and clinical overviews)
• Reporting safety updates and recommendations to senior management and decision-making committees

• Chairing internal multidisciplinary safety and benefit-risk committees
• Representing the patient safety function in internal and external meetings
• Contributing to the ongoing development of patient safety practices by staying current with regulatory changes, methodological advancements, and healthcare trends

• Medical degree with clinical and/or clinical research experience
• Experience in pharmacovigilance with strong understanding of global PV regulations
• Knowledge of clinical development processes and regulatory submissions
• Experience in cardiovascular, renal, hepatic, or metabolic diseases is desirable
• Strong interpersonal, communication, and teamwork skills
• Commitment to ethical standards, quality, and patient safety
• Fluency in English (written and spoken)

• Extensive experience in global pharmacovigilance and risk management, including clinical development and post-marketing safety
• Broad understanding of pharmaceutical industry practices and emerging trends in patient safety
• Strong knowledge of regulatory requirements and compliance needs in major markets
• Proven project management and leadership abilities