Job Description

With multiple programs in late-stage development, a robust clinical pipeline, and strategic alliances with top-tier biopharma partners, our client is entering a pivotal phase of growth. They’re looking for a seasoned drug safety physician to help shape a proactive, global pharmacovigilance function that will scale with the pipeline.

About the Role

The Vice President of Drug Safety & Pharmacovigilance will be accountable for drug safety and pharmacovigilance activities for all compounds and products. This role will be responsible for safety organization and activities, including case operations, regulatory compliance, drug safety quality management, signal detection, risk management, molecule oversight, and risk communication. This position is responsible for developing and executing plans to support the overall corporate goals of developing and delivering safe medicines to patients.

Responsibilities

• Provide proactive leadership and expertise to drug safety and pharmacovigilance functions, including activities for investigational and marketed products.
• The VP of Drug Safety and Pharmacovigilance will identify safety signals in the investigational programs and manage those signals.
• The management of safety signals requires clinical acumen to prioritize signals.
• The VP is expected to proactively interact with investigators and other medical staff to manage clinically important safety signals arising in clinical trials while ensuring their resulting clinical data ultimately supports labeling that clearly articulates the safe use of products.
• Manage all drug safety and pharmacovigilance operational compliance functions, and ensure compliance with applicable Pharmacovigilance regulations, guidelines, and agreements with Business Partners for the product portfolio at all stages of the product lifecycle.
• Responsible for safety organization and activities, including case operations, regulatory compliance, drug safety quality management, signal detection, risk management, molecule oversight, and risk communication.
• Lead Safety trend analyses, signal detection activities, and Safety data reviews.
• Ensure competent medical evaluation of all relevant safety information, including that from partners, regulatory agencies, clinical trials, scientific literature, and non-clinical studies for ongoing surveillance and signal detection.
• Provide clinical expertise and medical review of aggregate/individual post-marketing and clinical trial adverse event reports.
• Participate in developing signal detection strategies and programs (i.e., Spotfire, elluminate, etc.).
• Develop and maintain comprehensive PV agreements that facilitate an efficient exchange of safety information and an optimized global strategy for managing the risk-benefit profiles of the company's product.
• Assure required safety submissions are of the highest quality and submitted within regulatory timelines, including DSURs, PBERs, and PADERs.
• Support development and provide medical expertise to investigative brochures, Informed Consent forms, clinical trial (CT) protocols and amendments, and other related documents as it pertain to safety.
• Implement project-specific process documents such as Safety Management Plans, Safety Reporting Plans, and other Safety/Pharmacovigilance plans.
• Oversee the Risk Management and Risk Minimization Plans for all products.
• Contribute drug safety principles related to IB, SOPs, CT Protocols and Amendments, Informed Consents, Clinical Study Reports.
• Lead in the development of safety core data sheet and reference safety information (RSI).
• Manage all safety processes to ensure process flow is managed efficiently and effectively, including formulating and recommending process improvement changes.
• Provide oversight to all contractors and service providers that are part of the Safety team.
• Interact with Regulatory Authorities on all safety-related audits.
• Collaborate with cross-functional teams to provide clinical knowledge and medical guidance related to global safety/safety compliance.
• Support preparation for US and Non-US filing and labels.

Qualifications

• MD Degree or equivalent degree.
• At least three years of clinical experience post-qualification or equivalent.
• A minimum of 10 years of drug safety operations and pharmacovigilance experience, and at least five years of proven experience in a senior leadership role.
• Strong experience in PV operation and PV risk management is required.
• Demonstrated understanding of regulations, knowledge, and practices required for PV, including local/international GPvP guidelines, ICH guidelines, and industry practices.

Required Skills

• Highly developed scientific and analytical knowledge base and an excellent understanding of good pharmacovigilance practices and current regulations.
• Sound clinical judgment.
• Demonstrated record of being decisive and accountable for organizational performance with successful outcomes.
• Demonstrable leadership ability, skilled in strategic thinking, building alignment, innovative problem-solving, and driving team performance.
• Demonstrable expertise in clinical trials and post-marketing pharmacovigilance, signaling methodologies and tools, and working with outsourced service providers to achieve high-quality results.
• Superior verbal, written, and presentation communication skills in relating to colleagues and associates both inside and outside the organization.
• Detail-oriented and data-driven.

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