Director Drug Safety

• Provide review of individual cases and cumulative line listings (aggregate safety data)
• Support the development of safety selections for Clinical Investigators Brochures risk profiles protocols and regulatory reports (e.g. DSUR IND Annual Reports Clinical Study Reports and 6monthly SUSAR line listings)
• Perform continuous safety assessments of products in clinical development. Provide an initial assessment of medical information and lab results write narratives and conduct appropriate followup for serious adverse events.

• Provide expert guidance and leadership in Pharmacovigilance and GCP/ICH compliance regulations and guidelines as well as in applicable Sangamo and/or partner SOPs
• Global safety database oversight including QC of configuration dataentry 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 leaders and stakeholders
• 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 compliancerelated 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
• Partners with other departments including Clinical Operations 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 Sangamo development and future marketed products. This will include system and/or vendor selection implementation and validation as needed

• Advanced degree in life sciences nursing pharmacy or medicine.
• 8 years experience in global Drug Safety/Pharmacovigilance for a biotechnology or pharmaceutical company in the clinical trial and post marketing environments.
• 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 problemsolving skills with a broad perspective
• Thorough understanding of the clinical drug development process and drug safetys role therein
• Excellent interpersonal skills decisionmaking and ability to adapt to a dynamic and complex regulatory and business environment
• 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 crossfunctional project team member

• Ability to be independent and move forward processes and work
• Demonstrated leadership to drive results that are needed to achieve company objectives in accordance with Sangamos culture and core values

Required Experience:

Director