Director, Drug Safety Operations
Location: Emeryville, CA
Department: Drug Safety & Pharmacovigilance
The Director, Drug Safety Operations will be responsible for creating, directing, and managing the company’s infrastructure and staff to support the operational aspects of the pharmacovigilance system, and adheres to all global regulatory requirements and internal processes and procedures. The qualified candidate will have experience in and perform multiple activities related to the overall global safety operations strategy across the portfolio including Zogenix case management, database strategy, vendor oversight, compliance, inspection readiness, budget, contracts and training. The Director of Safety Operations reports to the VP, Safety and Pharmacovigilance.
Essential Duties and responsibilities
- Provides strategic planning, implementation, and management of Global Patient Safety (GPS) Pharmacovigilance Operations activities.
- Responsible for managing internal and external staff allocated to operational GPS activities, creating a highly efficient team across insourced and outsourced resources.
- Provides expert guidance and leadership both internally and externally based on in-depth knowledge of development and post-marketing safety requirements, per ICH; US and international regulations and guidelines; and Good Pharmacovigilance Practice (GPvP).
- Builds and implements pharmacovigilance systems fully compliant with the applicable worldwide Health Authority PV regulations.
- Ensures that the GPS Database supports the department needs, including specific workflows and reporting/querying functionalities.
- Provides oversight of systems and MedDRA updates in collaboration with the relevant vendor(s).
- Manages vendors and business partners. Provides vendor oversight and management for all outsourced or insourced PV activities, including establishing and monitoring key quality and compliance metrics.
- Develops and implements an inspection readiness program with the contribution of other GPS and non-PV stakeholders.
- Responsible for a compliant and quality execution of all operational activities related to case management and related activities.
- Oversees timely submissions of expedited reports to the FDA & other health authorities.
- Identifies deviations and applicable corrective and preventive actions to maintain the compliance to reporting at its highest level.
- Establishes a system for prevention and correction of deviations to compliance with internal and external stakeholders, in collaboration with the Zogenix Quality group.
- Oversees the set-up of new safety projects, including development of study-specific Safety Management Plans and set up of safety systems and database configurations in the PV database to accommodate these trials and products.
- Contributes to, drafts and implements department SOPs and work instructions related to the GPS activities.
- Oversees aggregate reporting activities with providing accurate reports from the GPS database.
- Effectively collaborates with key stakeholders at all levels in the organization. including Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs and Manufacturing to develop compliant procedures in line with industry standards and best practices.
- Represents Drug Safety and Pharmacovigilance as a leader on project teams, other departments, and committees as needed
- Provide managerial support to one or more employees with overall responsibility of leading, training, and mentoring for effective performance
- Other duties as assigned
Core Competencies, Knowledge and Skill Requirements
- Credible knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes.
- Strong organizational, planning, prioritizing and problem-solving skills.
- Effective multi-tasking skills that can be applied in different and complex assignments and ability to work effectively under pressure and under strict timelines.
- Ability to work both independently and collaboratively and use own initiative.
- Ability to communicate effectively both locally and globally, internally and externally.
- Open to changes, suggestions and innovations, continuously on the look-out for work processes' improvements.
- Tolerance for ambiguity and ability to adapt quickly to a changing business environment.
- Highly resilient, tenacious and resourceful.
- Approachable, flexible and self-motivated.
- High attention to details.
- PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
- A degree in Life Sciences, with a post graduate specialization in Project or Business Management
- 10 years of experience in the pharmaceutical industry, predominately in drug safety/pharmacovigilance operations, having worked on both development and marketed products.
- Demonstrated leadership in building safety operations function and experience in vendor management.
- Experience of working in a cross functional team and strong project and business management skills.
- Experience in managing and supervising team is preferred.
- Operational expertise in ARGUS preferred.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)
- Ability to work on a computer for extended periods of time.
- Regularly required to sit for long periods of time, and occasionally stand and walk.
- Regularly required to use hands to operate computer and other office equipment.
- Close vision required for computer usage.
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds.
- Travel up to 20%