Pharmacovigilance Physician

Pharmacovigilance Physician Overview

• The Pharmacovigilance Physician will provide expert pharmacovigilance consulting for rare disease and oncology programs.
• Develop and implement safety strategies across clinical and non-clinical programs.
• Evaluate benefit-risk profiles and recommend risk mitigation strategies.
• Collaborate on regulatory communications and submissions regarding safety matters.
• Contribute to the development of safety-related documents, including protocols and investigator brochures.
• Support integrated summaries of safety for regulatory submissions.
• Engage with regulatory authorities to address safety concerns effectively.
• Provide strategic input to marketing authorization applications and new drug applications.
• Work remotely with flexibility for contract extension opportunities.

Pharmacovigilance Physician Key Responsibilities & Duties

• Develop safety strategies and conduct risk evaluations for pharmacovigilance programs.
• Analyze clinical and non-clinical safety data to identify potential risks.
• Prepare and review safety documents for regulatory submissions.
• Collaborate with cross-functional teams to address safety-related issues.
• Provide expert recommendations for risk mitigation and remediation strategies.
• Support regulatory negotiations and communications regarding safety matters.
• Contribute to the development of investigator brochures and investigational medicinal product dossiers.
• Ensure compliance with ICH guidelines and pharmacovigilance regulations.
• Monitor emerging safety concerns and provide timely recommendations.

Pharmacovigilance Physician Job Requirements

• Doctoral degree (MD) with a minimum of 10 years of pharmacovigilance experience.
• Proven knowledge of epidemiology, statistics, and critical analytical skills.
• Solid understanding of ICH guidelines and pharmacovigilance regulations.
• Experience in developing safety strategies and regulatory submissions.
• Ability to work remotely and adapt to contract-based roles.
• Strong communication skills for regulatory and cross-functional collaboration.
• Preferred 12 years of industry experience in pharmacovigilance.
• Expertise in rare disease and oncology safety programs.
• Capability to manage safety data and provide strategic recommendations.