Pharmacovigilance Physician

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

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. Also, they will conduct medical reviews of safety reports (ICSRs), identify risks, and ensure compliance with global regulations

• Provide clinical and scientific leadership within the pharmacovigilance function.
• Engage cross-functional internal workstreams including therapeutic area development, biostatistics, clinical operations, and regulatory affairs.
• Provide clinical input to the design of clinical trials, signal detection and management activities, post authorization studies, risk minimization, and risk communication
• Perform 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
• Lead clinical safety and benefit risk sections of regulatory documents and preparation for meetings with regulatory and public health authorities as well as advisory committees
• Perform post-marketing surveillance and regulatory reporting, as needed
• Guide the operations of contract research organizations
• Serve as an exemplary leader, mentor and trainer

• 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
• 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.

• 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 - 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.

• 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!

The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.

Disclaimer

Nuvation Bio, Inc. is an equal opportunity employer, and, in accordance with applicable federal, state, and/or local law, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.

This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Note to all external Recruiters & Staffing Agencies
All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.