Title: Director / Senior Director, Drug Safety Operations
Manager: Vice President, Drug Safety
Department: Clinical Development
Location: Brisbane or Richmond, CA
The Sr. Director/Director of Drug Safety Operations will be responsible for implementing and management of effective, high quality and efficient processes in compliance with global regulatory requirements and pharmacovigilance best practices.
- Provide expert guidance and leadership in Pharmacovigilance and GCP/ICH compliance regulations and guidelines, as well as in applicable Company and/or partner SOPs
- Global safety database oversight including QC of configuration, data-entry conventions and MedDRA dictionary versioning.
- Management of workload and resources to meet global regulatory timelines
- Oversight of safety vendors activities
- Provide strategic management and policy proposals for the operations team
- Ensure consistency of work practices across teams both locally and globally
- Accountable for identification, initiation, development and implementation of PV process improvements, tools, systems and procedures to enable excellence and consistency in operations in collaboration with other managers/supervisors
- Provide safety/pharmacovigilance guidance to clinical trial project teams and/or external partners to develop safety reporting procedures and logistics for clinical trials, e.g. reconciliation with clinical database.
- Responsible for the oversight, management and communication for all future global business partner safety data exchange agreements and other contracts as applicable and ensure compliance with data exchange activity
- Work with QA/Compliance with respect to inspection readiness and ensure operational procedures and training are compliant with current pharmacovigilance standards.
- Develop and maintain SOPs, policies, procedures and standards for case processing
- Ensure compliance-related investigations, and development and implementation of corrective actions for deviations from case processing procedures are performed accurately and on time
- Interact with global country operations- colleagues related to operational issues/data quality issues
- Supports VP of Drug Safety relative to risk management activities.
- Partners with other departments including Clinical Operations, Clinical Development, Regulatory Affairs, Legal to support clinical, medical and regulatory strategies, company goals as well as to communicate and address drug safety findings
- Assist in the preparation of relevant sections of clinical study reports, aggregate reports (DSUR, Annual Report), expedited safety reports and other regulatory filing documents
- Establish and maintain an electronic global safety database for tracking, storing, and reporting serious adverse events of all Company development and future marketed products. This will include system and/or vendor selection, implementation and validation, as needed
- Other duties as assigned
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Advanced degree in life sciences, nursing, pharmacy or medicine.
- At least 8 years’ experience in global Drug Safety/Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments. A minimum of 5 years of functional management experience overseeing PV staff
- A thorough understanding of the global PV regulatory environment with working knowledge of EU and US regulations, ICH guidelines, and GCP, a background in implementation and use of drug safety databases as well as extracting required listings and data from
- Effective project management skills, a demonstrated ability to provide critical and timely insight, and analytical problem-solving skills with a broad perspective
- Thorough understanding of the clinical drug development process and drug safety’s role therein
- The position demands excellent interpersonal skills, decision-making, and ability to adapt to a dynamic and complex regulatory and business environment
- This position also requires a commitment to process improvements, excellent organizational skills, excellent written and verbal communication skills, and a strong commitment to best practices, and the ability to work effectively as both a functional area manager as well as cross-functional project team member
- Computer literacy is essential
- Ability to be independent and move forward processes and work
- Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s culture and core values