Manager, Global Case Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage the internal submission process for regulatory agencies, partners, and internal teams.

• Monitor and track ICSR timelines to guarantee compliant submissions to regulatory bodies, business partners, and CROs.

• Identify challenges and propose solutions to support regulatory submission schedules and deadlines.

• Ensure the accuracy and completeness of both electronic and hard-copy regulatory submissions.

• Facilitate interactions with regulatory agencies regarding submission content review.

• Contribute to organization-wide initiatives aimed at process improvement.

• Support PV Operations and investigate issues related to safety and compliance.

• Identify underlying causes for delayed ICSR submissions and implement corrective measures.

• Oversee the scheduling and timelines for safety reports.

• Monitor compliance with regulatory deadlines and submission criteria.

• Collaborate with safety surveillance and case processing teams to meet submission deadlines.

• Evaluate the impact of new regulations on safety database reporting rules and manage updates accordingly.

• Participate in cross-functional meetings as the submissions lead.

• Organize and monitor safety information requests and their responses.

• Generate and utilize reports to track daily case workload, impending reports, worklists, bottlenecks, and resource deficiencies.

• Engage in the setup and maintenance of adverse event workflow processes, policies, and standard operating procedures.

• Ensure adherence to corporate and departmental standard operating procedures.

• Contribute to the establishment of standardized practices, procedures, metrics, and performance measures.

• Assist with health authority responses related to ICSR.

• Provide support and backup to the Global PV Workflow Associate.

• Execute other tasks as directed by management in Drug Safety and Pharmacovigilance.

• Manage and oversee E2B warnings and failures.

⛳️ Requirements

• Adequate experience and comprehensive understanding of global safety reporting regulations and guidelines, including FDA, ICH, and EU regulations, as well as pharmacovigilance requirements.

• Familiarity with the ARGUS Safety Database.

• Experience in case management and metrics related to safety report submissions.

• Knowledge and prior experience in case processing.

• Exceptional technical skills with the ability to understand and integrate scientific data from diverse sources.

• Strong communication and writing capabilities.

• Proficient computer skills with demonstrated experience in Microsoft Word, Excel, PowerPoint, and Outlook.

• Ability to apply organizational policies or regulatory procedures to various situations.

• Capacity to work under pressure and meet stringent timelines.

• Ability to operate effectively within a matrix environment.

• Strong attention to detail coupled with problem-solving skills.

• Excellent project management capabilities and the ability to coordinate internal and external resources.

• Proven competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations.

• Bachelor of Science or a related healthcare degree is preferred; this requirement may be waived for relevant experience.

• A minimum of 5 years of experience in drug safety is required.

• Demonstrated proficiency in the functionality of safety databases.

• Experience in global Drug Safety case processing.

• Safety experience related to AE/SAE reports, narratives, queries, safety databases, and regulatory submissions.

• Willingness to travel approximately 10% of the time.

🏝️ Benefits

• Comprehensive coverage for medical, dental, vision, and prescription drugs.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement program.

• Assistance with student loans.

• Generous matching for 401(k).

• Flexible time off policy.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Opportunities for incentives.