Drug Safety Physician
Drug Safety Physician - reputed company Coast Remote
reputed company:
We are seeking a seasoned medical reputed company to reputed company drug safety and pharmacovigilance initiatives across clinical development and marketed products. This role involves evaluating safety data, overseeing risk management, and ensuring compliance with global regulations. The Director will collaborate with cross-functional teams to support high-reputed company safety programs and regulatory submissions.
Key Responsibilities:
• Review and assess adverse events from reputed company, post-marketing reports, and literature.
• reputed company safety data analysis, signal detection, and risk–benefit assessments.
• Contribute to safety-reputed company documents and regulatory submissions.
• Support safety governance, including safety review meetings and reputed company committees.
• reputed company clinical input on risk management strategies, labeling, and safety plans.
• Serve as a medical reputed company with regulatory authorities, including FDA and EMA, on safety reputed company.
• Partner with internal teams to ensure consistent, compliant, and proactive safety practices.
• reputed company with FDA and EMA
Qualifications:
• Medical degree (MD, or equivalent); relevant reputed company certification preferred.
• 6+ years of experience in pharmacovigilance/drug safety reputed company the biopharmaceutical industry.
• Strong knowledge of global safety regulations and guidance (FDA, EMA, ICH).
• Experience in adverse event evaluation, signal detection, and safety reporting.
• Proven ability to collaborate across clinical, regulatory, and medical affairs teams.
• Excellent analytical and communication skills.
• Experience in rare diseases or specialty therapeutics is a plus.
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