Drug Safety Manager

Job Description SummaryPrimarily responsible for oversight of all activities related to the global case processing of Individual Case Safety Report (ICSR) information from all sources including post-marketing, clinical trials and published literature. This role is also responsible for compliance root cause analysis, SOP review and revision, coordination of training, decision-making to support regulation changes, and driving process improvement. The Drug Safety Manager, although not a People Leader with direct reports, oversees and directs day-to-day activities of the Case Processing team to ensure high compliance, consistency across global procedures, and continuous improvement.Job Description

Job Description

• Monitor Global Case Processing activities (Intake, Triage, Data Entry, Medical Review, Quality Control/Finalization, Distribution, and due diligence/follow-up) for drug and device reports from all sources, including post-marketing, clinical trials and published literature, ensuring accurate and timely handling.
• Manage GPV case processing mailbox including assigning email items to team members, performing daily check and responding to any inquiries as needed.
• Assign cases in the safety database as needed and distribute work to team in relation to changing priorities and workload with optimized allocation of resource.
• Perform workflow tasks in any step, including accurate coding of MedDRA terms, preparation of case narratives, and review of expedited reports, as needed, in accordance with GPV processes and global regulatory requirements and guidelines.
• Provide oversight and mentoring, peer advising and coaching to team members on case processing or product knowledge.
• Independently troubleshoot questions and issues with team, including database functionality, case processing conventions, and report submission failures; provide guidance based on experience, regulatory requirements, and Data Handling Conventions.
• Lead effective team meetings and assist with preparation of meeting agenda, minutes tracking and storage.
• Vendor oversight as needed, collaborating with external project leaders and teams to develop solutions, provide appropriate training, and monitor quality.
• Support Manager/Director of Case Processing with metrics collection and tracking periodically, perform gap analysis if needed and develop continuous improvement plan/activities, to ensure the meet of internal KPI target, compliance with high quality.
• Provide Compliance group with root cause analysis and CAPA for late submissions. Re-train team and update processes as appropriate.
• Initiate and drive process improvements by participating in updates of Work Instructions, SOPs, and other guidance documents.
• Serve as pharmacovigilance resource and subject matter expert of case processing during inspections and audits.
• Serve as pharmacovigilance liaison and resource to internal and external groups regarding case processing and reconciliation (e.g., Regulatory Affairs, Medical Affairs, Quality Assurance, Clinical Development, CROs, etc.)
• Act as liaison between local LSU and global case processing teams to address domestic case related issues.
• Provide PV support for clinical trials, request study configurations, and develop study-specific job aids, as needed.
• Support preparation and submission of aggregate reports, as needed.
• Participate in database projects and user acceptance testing, acting as SME for case processing.
• Contribute to the completion of complex projects, manage time effectively, and develop plans for individual project activities within the team.
• Maintain expertized knowledge for pharmacovigilance regulations, guidelines and company SOPs and conventions and for safety profile of company products.
• Ensure availability of current organization charts, job descriptions, Curriculum Vitae and training records for safety personnel.
• Provide pharmacovigilance trainings to local staffs and business partners upon request.
• Support local response to safety related requests from local Health authority upon request.
• Add Chinese translation for domestic cases in GAED to allow for E2b R3 reporting to NMPA upon request.
• Any other tasks assigned by line manager.

Qualifications and Requirements:

• Bachelor's degree or above, major in medicine, pharmacy, epidemiology or related major
• Minimum 5 years of pharmaceutical/biotechnology industry experience in case processing, including clinical trial and post-marketing experience. Global experience preferred.
• Proficient in all aspects of case processing, including case assessment (validity, seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review, expedited report review and scheduling, and follow-up with reporters.
• Proficient in database functionality and business workflow to be able to perform root cause analyses and troubleshoot reporting issues.
• Minimum 1-2 years of PV Compliance experience such as root cause analysis for delayed reporting or deviation and CAPA management.
• Proficient in Case Processing related SOP review and revision
• Strong knowledge of global and local PV regulations and guidelines pertaining to collection, processing and reporting of adverse event.
• Computer literacy (e.g. Microsoft Office applications, Smartsheet).
• Fluency in spoken and written English.
• Strong organizational skills and communication capability.
• Shall be willing to submit to a background investigation, including for example, verification of past employment, criminal history, and educational background.

Desired Characteristics:

• Argus user experience preferred.
• Training and mentoring experience preferred.
• Ability to independently manage multiple projects or responsibilities in addition to everyday case processing workload, and flexibility to shift priorities quickly in response to business needs.
• Demonstrated initiative, teamwork, accountability/ownership and leadership of small projects or teams.
• Consistent ability to communicate and collaborate effectively with internal team members, extended PV team, cross-functionally with other departments, and externally with vendors, partners and customers. Ability to tailor message to specific audience.
• Ability to inspire team and lead by example, manage team conflicts, and influence opinion leaders/stakeholders.
• Health Care Professional experience preferred

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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.

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.

Additional Information

Relocation Assistance Provided: No

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