Safety Physician

Job Summary

To support a clinical-stage biopharmaceutical company, the remote Safety Physician will develop patient-centric risk management strategies, oversee safety activities for investigational compounds, and manage safety issue responses while ensuring compliance with regulatory requirements.

Key responsibilities

• Develop proactive risk management strategies and oversee benefit-risk assessments for investigational products
• Plan, manage, and analyze Safety/Pharmacovigilance activities for study medications, including serious adverse event reviews
• Provide clinical support for regulatory submissions and lead safety data review meetings with clinical teams

Required qualifications

• Medical degree with extensive clinical or research experience
• At least 10 years of experience in Pharmacovigilance and Risk Management within the pharmaceutical or biopharma industry
• Significant knowledge of clinical development regulations and experience with regulatory submissions
• Proven leadership and project management skills, preferably with experience in Oncology
• Strong understanding of ICH, GCP, and FDA/EMA guidelines and regulations