This position will provide leadership and direction to the Drug Safety operations for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Cytokinetics clinical trials.

Responsibilities

• Manage SAE/SUSAR reporting activities for all investigational drugs
• Manage preparation and processing of internal and external SAE reports
• Review incoming adverse events to determine action required
• Oversee maintenance of a hosted electronic database for tracking, storing, and reporting serious adverse events from Cytokinetics clinical trials.
• Ensure corporate compliance with domestic and international adverse event reporting requirements for all products in worldwide development programs
• Collaborate with partners on the exchange of safety data, safety monitoring, and the safety profile of investigational drugs as defined in Pharmacovigilance Agreements
• Lead preparation of safety-related plans with partners and CROs
• Provide guidance and support to project teams for safety-related areas, including protocol development and study conduct
• Contribute to preparation of relevant sections of clinical study reports, annual reports, expedited safety reports and other regulatory filing documents
• Coordinates pharmacovigilance Quality Auditing preparation
• Coordinates root cause analysis and implementation of corrective action and preventing action (CAPA) after internal audits and inspections
• Assist with preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, etc.
• Train staff and external CRO’s on drug safety principles and procedures
• Manage and mentor staff and assign responsibilities as appropriate to meet timelines and quality metrics
• Respond to safety-related queries from regulatory authorities or Ethics Committees, if needed
• Collaborate to ensure alignment among case handling, aggregate reporting, and signal detection activities

Qualifications

• Advanced degree in life sciences, nursing, pharmacy, or medicine
• 10+ years pharmaceutical industry drug safety experience
• Knowledge of and experience with international regulatory adverse event reporting requirements
• EudraVigilance electronic reporting of ICSRs experience
• Hands-on experience with adverse event case processing
• Proven experience and effectiveness at training and mentoring drug safety staff
• Excellent knowledge of MedDRA coding and WHODrug coding
• Ability to work independently, establish functional priorities and execute on goals
• Excellent interpersonal communication skills and ability to work effectively as part of teams
• Experience in neurology and/or cardiovascular drug development desirable.