Bausch Lomb

Makes eye medicines, lenses and surgical devices

Specialist - Gdcm

Regulatory & Quality (Life Sciences)Updated on Nov 14

Full-timeBeijing, ChinaNo salary listedIn-person

About the Job

Requirements

Translate and summarize Chinese-language complaint source information into English.
Follow standard operating procedures, forms and work instructions.

Responsibilities

Receive, document and evaluate complaint information, including complaints with or without adverse events.
Communicate with physicians, physicians’ staff and/or patients as required to obtain pertinent complaint information.
Escalate critical or unusual events to management in accordance with established procedures.
Liaise with Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and Research and Development to gather input for medical device event reports.
Conduct and document reportability assessments for complaints and upload documentation into the complaints management system in accordance with applicable local laws and regulations.
Process complaints in a timely manner and ensure China local reporting decisions are recorded or attached in the complaints management system before complaint closure.
Compile case and process metrics.
Support communication with the local health authority, including preparation or submission of medical device event reports as required by applicable laws and regulations.
Support preparation of responses to competent authority inquiries related to medical device report submissions for serious injury or device malfunction.
Meet complaint-handling target metrics and escalate issues when necessary.
Maintain complaint records and supporting documentation according to company procedures and local record-retention requirements.
Provide input to revisions of standard operating procedures, forms and work instructions when process gaps or improvement opportunities are identified.
Support local compliance audits, external regulatory agency inspections and Notified Body audits, including retrieving complaint records and explaining process steps.
Support root cause investigations and participate in nonconformance or corrective and preventive action activities for Global Device Complaints Management as required.
Support complaint-handling trending activities.
Generate complaint data reports for other departments as requested.
Support generation and tracking of periodic reports requested by the National Medical Products Administration or Notified Bodies.
Identify opportunities to improve complaint handling and medical device event reporting processes.
Support department projects and participate in cross-functional projects as required.
Cross-train and serve as Deputy Local Person for Pharmacovigilance as assigned, assisting with adverse-event and individual case safety report intake, translation, reconciliation, follow-up, forwarding to Global Pharmacovigilance Risk Management, and submission to competent authorities and partners.
Support applicable adverse-event reporting channel oversight; aggregate report scheduling, preparation and submission; and responses to regulatory queries or comments.
Conduct local literature searches and maintain the China Pharmacovigilance System Master File.
Support regulatory intelligence and risk-management activities, including risk minimization, safety variation implementation and urgent safety communications.
Review and maintain safety data exchange agreements and pharmacovigilance procedural documents.
Maintain curriculum vitae, job descriptions and organization charts.
Support pharmacovigilance audits, inspections, nonconformance and corrective and preventive action activities, training, Global Pharmacovigilance Risk Management training and teleconferences, and related documentation.
Support delegated Chinese Qualified Person Responsible for Pharmacovigilance duties, provide competent-authority contact availability when required, and participate in other assigned global or Asia-Pacific pharmacovigilance initiatives.
Perform other duties as assigned.

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Key Activities / Responsibilities:

Support the analysis and management of information regarding medical device complaints with and/or without adverse events, including follow-up, case processing and assessment for post-marketing activities including:
- Receive, document and evaluate complaint information
- As required, communicate with physicians, physician’s staff and/or patients to obtain pertinent complaint information.
- Escalate critical and/or unusual events to management in accordance with established procedures.
- Liaise with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input into medical device event reports.
Conduct and document reportability assessments for complaints (with or without an adverse event) and upload the documentation into the company complaints management system in accordance with applicable local laws and regulations.
- Ensure complaints are processed in a timely manner
- Ensure the China local reporting decision is recorded and/or attached in the company complaints management system prior to closure of the complaint.
- Compile case and process metrics.
- Support communication with the local health authority, including preparation and/or submission of medical device event reports as required by applicable local laws and regulations.
Support the preparation of responses to competent authority inquiries associated with medical device report submission (Serious Injury and/or Device Malfunction).
Ensures complaint handling target metrics are met on a routine basis and escalate issues when deemed necessary.
Translate and summarize Chinese-language complaint source information into English for review by Global Device Complaints Management and the Complaint Evaluation Center.
Maintain complaint records and supporting documentation in accordance with company procedures and local record retention requirements.
Follow standard operating procedures, forms and work instructions, and provide input to revisions where process gaps or improvement opportunities are identified.
Support local compliance audits, external regulatory agency inspections and Notified Body audits as assigned, including retrieval of complaint records and explanation of process steps.
When required, support root cause investigations and participate in NC (Nonconformance) or CAPA (Corrective and Preventive Action) for GDCM activities.
Supports complaint handling trending activities.
Generate complaint data reports for other departments as requested.
Support the generation and tracking of periodic reports as requested by government agency (NMPA) and/or Notified Bodies.
Identify opportunities to improve complaint handling and medical device event reporting processes.
As required, support department projects and/or participate in cross functional projects.
As assigned, cross train and serve as Deputy LPPV to assist with PV activities including but not limited to AE/ICSR intake, translation, reconciliation, follow-up, forwarding to GPRM, and submission to competent authorities and partners; applicable AE reporting channel oversight; aggregate report scheduling, preparation, submission and responding to regulatory queries or comments; local literature search; China PSMF maintenance; regulatory intelligence; risk management related activities (risk minimizations, safety variations implementation, urgent safety communications, etc.); SDEA review and maintenance; PV-related procedural documents management; CV, JD and organization chart maintenance; PV audit and inspection support; PV related NC/CAPA activities; PV training and participation in GPRM training and teleconference; PV-related documentation; delegated Chinese QPPV support; competent authority contact availability when required; and other assigned global/ APAC PV initiatives.
Performs all other duties as assigned.

This position may be available in the following location(s): CN - Beijing 1

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

About the Company

Bausch Lomb

Makes eye medicines, lenses and surgical devices

Bausch + Lomb develops and sells eye-health products for patients, consumers and clinicians, spanning everyday vision correction, prescription treatment and eye surgery. Its portfolio combines contact lenses and lens-care solutions with medicines for eye conditions and equipment used in cataract, retinal and refractive procedures. The company also sells surgical consumables and implanted lenses, supplying products used both at home and in clinical settings. It earns revenue through product sales across its vision care, pharmaceuticals and surgical businesses. Founded as an optical goods store in Rochester in 1853, Bausch + Lomb is headquartered in Vaughan, Ontario, with its U.S. headquarters in Bridgewater, New Jersey.

Company size: 10,001+
Company stage: IPO
Headquarters: Vaughan, Canada
Founded: 1853

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