This position provides leadership and strategic direction to the Global Patient Safety case and study Operations department for adverse event case management, operational oversight of drug safety case management vendor, safety submission execution and compliance, and cross functional collaboration to support risk management and pharmacovigilance activities for the Global Patient Safety department.
Requirements
- Responsible for leading the global ICSR activities to comply with global ICSR regulations.
- Manage and lead the team who prepares, processes, and performs reporting activities of SAE/SUSAR reports for all Exelixis investigational drugs.
- Oversee processes, training and compliance of external case management vendors.
- Ensure submission compliance with business partners, CROs and global regulatory authorities.
- Provide oversight of ICSR regulatory submissions to ensure compliance with global regulations.
- Ensure data reconciliation of the safety and clinical databases for Serious Adverse Events.
- Effectively utilize metrics to assess productivity, opportunities for workflow and quality improvement, and to measure effectiveness of change initiatives.
- Work with VP, Pharmacovigilance and other GPS colleagues to ensure PV compliance and inspection readiness.
- Support data readiness for generation and submission of aggregate reports (e.g., DSUR, PBRER, and IDMC listings).
- Collaborate with other GPS functions to ensure alignment among case management, aggregate reporting, and signal detection activities.
- Collaborate with clinical teams in the preparation of and updates to safety-related study documents (e.g., Protocols, ICFs, Safety Management Plans).
- Collaborate with the Quality Management function to develop or update Standard Operating Procedures and Work Instructions for GPS, which are integrated and fully aligned.
Benefits
- 401k plan with generous company contributions
- Group medical, dental and vision coverage
- Life and disability insurance
- Flexible spending accounts
- Discretionary annual bonus program
- Sales-based incentive plan
- Opportunity to purchase company stock
- Long-term incentives
- 15 accrued vacation days in their first year
- 17 paid holidays including a company-wide winter shutdown in December
- Up to 10 sick days throughout the calendar year
