Senior Manager, Safety PV Ops

Role Overview

• Provide management role to the oversight of the Global Patient Safety case management, operational oversight of drug safety case management vendor, safety submission compliance, and cross-functional collaboration to support risk management and pharmacovigilance activities for the Global Patient Safety department.
• Responsible for leading the global ICSR activities to comply with global ICSR regulations.
• Manage and lead the assigned program(s) to support PV operations activities. These include study start up preparations up to closure working with various stakeholders.
• Oversee processes, training and compliance of external case management vendors, CAPA development.
• Provide oversight and ensure submission compliance with business partners, CROs and global regulatory authorities.
• Support Inspection Readiness and During Inspection.
• Support general data output/requests for info.
• 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 PV management and other cross-functional team members to ensure PV compliance and inspection readiness.
• Support data readiness for the production and submission of aggregate reports (e.g., DSUR, and IDMC listings).
• Collaborate with other internal and external 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, PVA or SDEA, DMP, ECCG plan, SAE Recon Plan, DTA Plan, Monthly Data Review, etc.).
• Collaborate with the Quality Management function to develop or update Standard Operating Procedures and Work Instructions for PV and Safety, which are integrated and fully aligned.
• Significant cross-departmental interactions with other Rayzebio functions, including Clinical Data Management, Clinical Operations, Clinical Development, and Quality Assurance groups.

Requirements

• BS/BA degree in related discipline and a minimum of 10 years of related experience; or, Equivalent combination of education and experience.
• Drug Safety and Pharmacovigilance including at least 8+ years of experience in Pharmacovigilance Operations.
• Working knowledge of and experience with international regulatory Adverse Event Reporting requirements.
• Proven experience and effectiveness at guiding PV vendor staff.
• Extensive knowledge of biotechnology/pharmaceutical sector drivers and practices.
• Demonstrates and excellent knowledge of relevant US and international regulations, guidance and initiatives governing both clinical trial and post-marketing safety environments.
• Demonstrates advanced skill and keen insight in gathering, sorting and applying key information to solve problems.
• Demonstrates strong organizational and planning capabilities by managing time, workload, and resources of a function.
• Leads and manages a functional area within a department to execute on team functional objectives that contribute to accomplishing common functional and departmental goals.
• Demonstrates high standards of verbal and written communication. Provides timely and appropriate information updates.
• Speaks clearly and confidently in one-to-one situations and effectively presents to audiences within and outside Exelixis.
• Fosters collaboration among team members. Encourages teams to align on common goals.
• Engages internal and external stakeholders to build relationships.
• Strong interpersonal skills and skilled at effectively resolving challenges by developing an agreed upon resolution.
• Develops procedures, tasks, and tools.
• Trains and mentors staff on departmental products, tools, and data sources.
• Develops and maintains knowledge of cross-functional products, tools, and data sources.
• Mentors junior team members.
• Contributes to performance reviews and professional development plans of team members.
• Capable of proactively assessing workload, trends, tasks, and priorities for cross-functional activity.
• Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short
• and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.