Senior Medical Director of Product Safety Teams

Our client is a top 10 global biopharmaceutical company. They have retained us to assist them in their search for a Senior Medical Director of Product Safety Teams for their immunology pipeline.

Major tasks and responsibilities include:

• Understanding and applying principles of pharmacology, chemistry, and non-clinical toxicology to effectively conduct safety surveillance.
• Responsible for safety surveillance of pharmaceutical, biological, and drug-device combination products.
• Take charge of and develop the strategy for critical pharmacovigilance documents, encompassing medical safety assessments, regulatory responses, and 15-day aggregate reports, and write these documents as necessary.
• Apply relevant regulatory guidelines for safety monitoring and the creation of pharmacovigilance documents as needed.
• Analyze, interpret, and synthesize aggregate safety data, and effectively communicate these analyses and interpretations to cross-functional teams and senior management.
• Independently write, review and provide input on technical documents.
• Take responsibility for overseeing and leading the strategy, including drafting key sections for periodic reports when necessary.
• Collaborate with the development medical lead to design and strategize study protocols and informed consents.
• Implement risk management strategies for assigned products.
• Proactively engage, inspire, coach, and mentor team members and colleagues.
• Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader.

We seek candidates with the following qualifications:

• Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.) with more than 2 years of residency and patient management experience is required; a Master of Public Health is preferred in addition to an MD/DO but is not required.
• Minimum of 5 years of Pharmacovigilance/Clinical Development experience in the pharmaceutical industry is required.
• Effectively analyze and guide the analysis of clinical data and epidemiological information.
• Ability to effectively present recommendations and opinions in group environments both internally and externally.
• Write, review, and provide input on technical documents.
• Work collaboratively and lead cross-functional teams.
• Evaluate and make independent decisions.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

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