About the role

Senior Manager overseeing Global Patient Safety case management and operational oversight of drug safety. Leading ICSR activities and ensuring compliance with global regulations in a biotechnology firm.

Responsibilities

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.
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.
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).

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.
Excellent knowledge of relevant US and international regulations, guidance and initiatives governing both clinical trial and post-marketing safety environments.
Advanced skill and keen insight in gathering, sorting and applying key information to solve problems.
Strong organizational and planning capabilities by managing time, workload, and resources of a function.
Demonstrates high standards of verbal and written communication.
Provides timely and appropriate information updates.
Strong interpersonal skills and skilled at effectively resolving challenges.

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.