Director, Case Processing

Job Description SummaryThe Director, Case Processing will report to Head of Drug Safety & Risk Management is and will oversee global individual case safety report (ICSR) collection, processing and reporting in accordance with applicable regulatory reporting requirements and company standard operating procedures. The Director, Case Processing Operations will serve as the leader for the Case Processing team.

Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used to enhance medical imaging exams. Used throughout all major disease area diagnostic and treatment pathways, PDx products support three patients every second around the world.

Job Description

Roles and Responsibilities

• Oversee global individual case safety report (ICSR) collection, processing and reporting in accordance with applicable regulatory reporting requirements and company standard operating procedures (SOPs).

• Develop, manage and mentor a team of safety professionals responsible for processing, regulatory reporting and distribution of ICSRs globally.

• Develop and/or update SOPs, processes and practices for safety data handling in accordance with drug safety and pharmacovigilance regulations, ICH standards, guidelines and industry best practices to ensure timely and compliant submissions to worldwide regulatory agencies.

• Develop and analyze metrics in order to plan short and long-term function deliverables and performance. Manage workload distribution in coordination with Drug Safety Team Lead/Workflow Manager.

• Partner with Case Processing, Quality/Compliance and Safety Systems management to ensure efficient and compliant case processing.

• Oversee PV vendor’s case management for GEHC PDx products including initial review and selection, performance monitoring, timely invoicing, and efficient budget utilization.

• Apply Lean methodology and lead Lean initiatives to improve efficiency/eliminate waste. Construct and provide recommendations within Case Processing but also extending to other functions within PV. Encourage mindset of continuous improvement.

• Serve as PV Subject Matter expert (SME) during audits and inspections in the areas of case processing/case management activities, case processing metrics, vendor oversight, etc.

• Oversee deviation and CAPA activities in relation to late ICSR submissions as well as deviations relating to case management processes as defined per the SOPs.

• Monitors industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to existing departmental policies, SOPs and systems.

Required Qualifications

• Degree/Certification in a Life Sciences discipline, Nursing or Pharmacy

• Minimum 5 years biotechnology or pharmaceutical industry experience with pharmacovigilance responsibility.

• End user experience/configuration of safety database (Eg: ARGUS); managing vendor to vendor communications; regulatory reporting proficiency and compliance (audit, metrics) experience.

• Up-to-date knowledge of current global regulations and industry guidelines governing pharmacovigilance.

• Ability to provide coaching, guidance, and feedback to help others excel on the job and meet key accountabilities.

• Skilled in Microsoft Office applications (Word, PowerPoint, Excel).

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening. 

For U.S. based positions only, the pay range for this position is $144,000.00-$216,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: July 11, 2024 Apply