[Hiring] Medical Director, Patient Safety @Nuvation Bio

Role Description

The Pharmacovigilance Physician will report to the VP of Pharmacovigilance. The PV/Drug Safety physician will be a medical professional responsible for ensuring drug safety throughout a product's lifecycle by detecting, assessing, and managing adverse events. They will conduct medical reviews of safety reports (ICSRs), identify risks, and ensure compliance with global regulations.

You will be responsible for:

• Providing clinical and scientific leadership within the pharmacovigilance function.
• Engaging cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
• Providing clinical input to the design of clinical trials, signal detection and management activities, post-authorization studies, risk minimization, and risk communication.
• Performing case series analysis of adverse events and review of passive surveillance data mining signals of disproportionate reporting as well as safety issues from other sources.
• Leading clinical safety and benefit-risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees.
• Performing post-marketing surveillance and regulatory reporting, as needed.
• Guiding the operations of contract research organizations.
• Serving as an exemplary leader, mentor, and trainer.

Qualifications

• MD, D.O. or non-US equivalent required.
• Residency training & board certification highly preferred.
• Clinical practice experience highly preferred.
• Experience working with public health agencies highly preferred.
• 2-4 years of prior experience in pharmacovigilance in an industry setting, either in a comparable role, or in clinical development.

Requirements

• Proven ability to collaborate effectively within dynamic and fast-moving technical teams to deliver high-quality results within established timelines.
• Utilize technology supporting pharmacovigilance (e.g. for signal detection and regulatory reporting).
• Interpret and integrate concepts and guidelines from FDA, EMA, PMDA and other regulatory agencies, government research organizations (e.g. NIH), public health agencies and nongovernmental organizations, and clinical practice groups.
• Investigate new safety issues.
• Communicate medical product benefits and risks to regulatory and public health authorities as well as the public.
• Ability to thrive in a fast-paced environment while providing appropriate attention to detail.
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills.

Behavioral skills to be successful...

• Problem-Solver: As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable: You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible: With a thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence: Curiosity, and a knack to figure out a way to build something better.
• Communication: Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability: Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability: Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.

Benefits

• Competitive Base Salary, Bonus, and Equity Plans.
• Unlimited Vacation and 10 Sick Days Annually.
• Excellent Medical, Dental, and Vision Coverage.
• 401K with Company Matching.
• And much more!