Executive Director, Pharmacovigilance

Work Requirement

This role will be based out of our Dublin or Redwood City office and is hybrid with a minimum of 3 days per week onsite. 

Key Responsibilities

• Provide dynamic leadership, strategic direction, and governance of patient safety and pharmacovigilance activities across our portfolio.
• Model and encourage adherence to the Zymeworks values and mission.
• Coach and mentor staff, including direct reports, ensuring appropriate levels of accountability.
• Support department operations to establish and maintain policies and procedures for Drug Safety Operations.
• Manage resources to ensure that approvals are timely and development objectives are met, including workforce planning and resource allocation decisions for departments. Hold leaders accountable to deliver departmental objectives within budget.
• Provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity, and completeness of safety information and to ensure consistency of medical coding of safety data.
• Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of potential product signals.
• Ensure ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.
• Support cross functional teams with respect to safety related issues as required.
• Provide input and review of responses to regulatory agency questions with related to drug safety/pharmacovigilance activities.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports, final study reports, IB, and other documents, as needed.
• Assess PV requirements for resources, equipment and systems to maximize efficiency.
• Support development and maintenance of product benefit-risk profile.
• Collaborate with business development team regarding direction for business development plan/strategy.
   

Education and Experience

• MD required; preference for experience in the areas of oncology, autoimmune or inflammatory disease
• Pharmacovigilance experience, including regulatory filing experience, within the biotechnology, pharmaceutical or related industry required. 
• Experience in at least two of the following regions: EMEA, APAC and North America.  

Skills and Abilities

• A minimum of 12 years total experience (combination of clinical, academic and industry) with 6+ years’ relevant industry experience including experience leading multidisciplinary teams
• Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people and resource management)
• Oversight experience of medical safety activities, operations and risk management strategies in pre and post marketing environments.
• Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.
• Robust knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.
• Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) preferred.
• Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.
• Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
• Entrepreneurial, small/high-growth company experience is preferred.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses excellent written and verbal communication skills.