Medical Director Drug Safety

Medical Director Drug Safety

September 23rd, 2019 by

Tanner and Associates is currently recruiting for a Medical Director to serve as a Global Safety Officer focusing on Bone Therapeutics.

Job Description:
The Global Safety Medical Director is responsible for dictating the direction and priorities of the Global Safety Team and is accountable for all product safety related decisions for assigned products and is the key company interface for this department. The Global Safety Medical Director is supported by the Global Safety Project Manager and is responsible for the timely communication of safety recommendations and/or actions from the Safety Team to internal and external stakeholders. This role leads single projects which can be of moderate or high complexity / scope or multiple projects of lower complexity closely collaborating with the Therapeutic Area Head.

Key Activities:
• Accountable for identification, assessment, and communication of potential safety signals as Team Leader for pharmacovigilance activities
• Lead response to regulatory safety queries
• Lead development of strategy and creation of product risk management plans including maintenance and updates
• Accountable for Global Safety Strategic Plan
• Safety representative for assigned products at meetings with Regulatory authorities, data safety monitoring committees, advisory boards
• Participate in planning, review and sign off of clinical trial safety documents for content including:
o Clinical Summary of Safety (CSS)
o 120 Day safety update
o Protocol safety sections
o CSRs
o ICFs
o Study safety monitoring plans
o Investigator Brochures

Preferred Qualifications:
• Drug safety, biotech/pharmaceutical or regulatory agency experience
• Board Certification by an accredited medical or surgical board e.g. ABIM, ABMS, EUMS
• Accredited subspecialty fellowship, e.g. oncology, endocrinology, epidemiology, clinical immunology, nephrology or clinical experience in clinical pharmacology
• Previous safety experience in oncology or bone disorders
• Previous clinical development experience in oncology or bone disorders

Basic Qualifications:
• MD or DO degree from an accredited medical school
• 2+ years of safety experience
• Completion of an accredited medical or surgical residency OR Clinical experience in either an accredited academic setting or private practice (including hospital based) setting

For more information, please contact Tanner and Associates at 760-598-3363 or email a CV at
Tanner and Associates

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