Director – Drug Safety Operations
Updated on 4/13/2024
Cytokinetics

201-500 employees

Develops drugs for muscle-related debilitating diseases
Company Overview
Cytokinetics stands out as a leader in the biopharmaceutical industry with its specialized focus on muscle biology and the development of first-in-class muscle activators and next-in-class muscle inhibitors, addressing debilitating diseases where muscle performance is compromised. The company's commitment to positively impacting patients' lives is reflected in its culture, fostering resilience and fortitude among its employees. Recognized as a top workplace by the San Francisco Business Times, Fortune, and Great Place to Work-Certified, Cytokinetics offers a supportive and rewarding environment that encourages innovation and industry leadership.
Biotechnology

Company Stage

N/A

Total Funding

$1.2B

Founded

1998

Headquarters

South San Francisco, California

Growth & Insights
Headcount

6 month growth

0%

1 year growth

7%

2 year growth

49%
Locations
Remote in USA
Experience Level
Entry
Junior
Mid
Senior
Expert
CategoriesNew
Operations & Logistics
Quality Control & Compliance
Requirements
  • 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
  • Experience in neurology and/or cardiovascular drug development desirable
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