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. Job Description Job Title Vendor QC Associate, Pharmacovigilance and Materiovigilance Business Title Vendor QC Associate, Pharmacovigilance and Materiovigilance Band Business Unit / Function Global Pharmacovigilance and Risk Management (GPRM) Job Code Location Mysore, India Objectives / Purpose of the Job The Vendor QC Associate, Pharmacovigilance and Materiovigilance will be responsible for directly engaging with the case processing vendor ensure appropriate case processing work performed by the vendor is of high quality and compliance and to improve quality and compliance of ICSR reporting and device events. The Vendor QC Associate will organize and perform quality review of ICSRs and device events processed by the vendor and ensure the cases are processed according to international regulation/guidance and company procedures. The Vendor QC associate will report to the Vendor and Site Manager. Key Activities / Responsibilities Ensure work performed by the vendor is of high quality and compliance. Review client/vendor working procedures and ensure they are up to date and complete. Review weekly and monthly case quality data to identify areas of improvement and training. Work cross functionally with other members of the department to ensure high quality cases and work efficiency with vendor delegated tasks. Participate in creation and implementation of vigilance SOPs as needed, including vendor procedures. Review and approve AE/SAE and device event reports for pre and post marketed product: clarify medical issues, issue queries, confirm case assessments, ensure clear narratives, revise MedDRA terms, and coordinate with external vendor and internal medical personnel as needed. Review relevant sections of Data Exchange Agreements as applicable to case processing Train and provide guidance to vigilance and other support staff for the vendor. Formulate and implement improvements as needed. Interact with compliance team to ensure necessary corrective and preventive actions have been taken to ensure case processing compliance. Support for any vigilance audit or inspection and ensure readiness at all times. Maintain the internal and external correspondence within the defined duties and activities and ensures relevant archiving of vigilance documentation if needed. Incoming vigilance Inspections/External vigilance Audits Assist with preparation of documentation for presentation during vigilance audits and inspections Non-Conformances/Deviations and CAPA documents Assist with preparation of Non-Conformances/Deviations and CAPA Documents related to vendor oversight Archive Archive PV related documents according to processes Perform any other vigilance related activities as assigned. Supervise Direct Reports No Scope of Position Member of Global Pharmacovigilance and Risk Management and Global Device Complaint Management departments who interacts with all internal and external stakeholders involved with the processing and reporting of individual case reports and device events by the vendor. Key Relationships Director Case Processing and Submission Global Pharmacovigilance and Risk Management team Global Device Complaint Management EEA QPPV, and members of the EEA QPPV Office Regulatory Affairs Medical & Scientific Affairs Clinical Affairs Finance Marketing R&D Management Representative Quality Department External customers (patients, health care professionals) External partners (distributors, business partners, Vendor(s) including CROs) Health authorities Qualifications / Training Knowledge/Skills: Global safety, pharmacovigilance, and materiovigilance regulations and guidelines; Use of safety database, preferably LSMV and CatsWeb; Working knowledge of scientific terms and medical terminology; Excellent oral and written communication skills; Excellent interpersonal skills and willingness to work in a team environment; Demonstrates consistent attention to detail; Highly organized and demonstrates understanding of workflow prioritization. Education: BS/MS/Doctorate degree in Pharmacy or Nursing, or related discipline or comparable field of study from an accredited college or university. Experience: minimum 3 years of Pharmacovigilance or Materiovigilance experience, preferably in individual case or device event review. Signature: Prepared by: Date: Approved by: Signature: Date Signature: Date This position may be available in the following location(s): IN - Gurgaon
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. Job Description Job Title Vendor and Site Manager, Pharmacovigilance and Materiovigilance Business Title Vendor and Site Manager, Pharmacovigilance and Materiovigilance Band Business Unit / Function Global Pharmacovigilance and Risk Management (GPRM) Job Code Location Mysore, India Objectives / Purpose of the Job The Vendor and Site Manager, Pharmacovigilance and Materiovigilance will be responsible for directly engaging with the case processing vendor to improve quality and compliance of ICSR reporting and device events. In addition, the Vendor and Site Manager will also organize and perform quality review of ICSRs and device events processed by the vendor and ensure the cases are processed according to international regulation/guidance and company procedures. This incumbent will oversee and manage the local Indian team and will report to the Director, Case Processing and Submissions. Key Activities / Responsibilities Act as a management level liaison between Bausch and Lomb and applicable vendors Supervise all project related activities Ensure work performed by the vendor is of high quality and compliance. Review client/vendor working procedures and ensure they are up to date and complete. Analyze metrics for critical vigilance processes to ensure high quality and compliance with SOPs and regulatory requirements. Review weekly and monthly case quality data to identify areas of improvement; initiate action plans to resolve recurrent and spikes in quality issues. Work cross functionally with other members of the department to ensure high level communication and work efficiency with vendor delegated tasks. Participate in creation and implementation of vigilance controlled documents (e.g., SOPs) as needed. Review and approve AE/SAE reports for pre and post marketed product: clarify medical issues, issue queries, confirm case assessments, ensure clear narratives, revise MedDRA terms, and coordinate with external vendor and internal medical personnel as needed. Participate to the oversight of the literature search process. Participate in submission and reconciliation of all individual case safety reports to ensure high quality and compliance. Review relevant sections of Data Exchange Agreements Train, mentor and provide guidance to pharmacovigilance/materiovigilance and other support staff including the vendor staff. Ensure all assigned projects follow company standard procedures for management and deployment of projects. Formulate and implement improvements as needed. Interact with compliance team to ensure necessary corrective and preventive actions have been taken to ensure compliance case processing. Assist the head of functional group to ensure inspection readiness. Support for any pharmacovigilance/materiovigilance audits or inspections. Maintain the internal and external correspondence within the defined duties, activities and ensures relevant archiving of PV documentation if needed. Provide support in establishing/maintaining vigilance systems Training Participate in the departments’ training activities, regular TCs organized by EEA- QPPV-Office, monthly and ad hoc reporting to EEA-QPPV Office Organize vigilance training for local affiliate employees including sales representatives as applicable Organize vigilance training for local contract partners (e.g., distributor) if applicable Incoming vigilance Inspections/External vigilance Audits Act as a contact point for audits and inspections for vendor related processes and inform GPRM PV Compliance Team and EEAQPPV-Office or materiovigilance functional heads. Manage or assist in managing vigilance audits and inspections from external regulatory agencies, partners, or corporate auditors Prepare documentation for presentation during vigilance audits and prepare and give guidance to staff (process owners) for an interview with auditor/inspector Non-Conformances/Deviations and CAPA documents Prepare and manage Non-Conformances/Deviations and CAPA Documents Archive Archive vigilance related documents according to processes Collaborate with Medical Affairs/Regulatory Affairs/Marketing/Business departments Perform any other vigilance related activities as assigned. Supervise Direct Reports Yes Scope of Position Member of Global Pharmacovigilance and Risk Management and Global Device Complaint Management departments who interacts with all internal and external stakeholders involved with the processing and reporting of individual case reports and device events. Key Relationships Director Case Processing and Submission Global Pharmacovigilance and Risk Management team Global Device Complaint Management EEA QPPV, and members of the EEA QPPV Office Regulatory Affairs Medical & Scientific Affairs Clinical Affairs Finance Marketing R&D Management Representative Quality Department External customers (patients, health care professionals) External partners (distributors, business partners, Vendor(s) including CROs) Health authorities Qualifications / Training Knowledge/Skills: Global safety and vigilance regulations and guidelines; Use of safety database, preferably LSMV and CATSWeb; Working knowledge of scientific terms and medical terminology; Excellent oral and written communication skills; Excellent interpersonal skills and willingness to work in a team environment; Demonstrates consistent attention to detail; Highly organized and demonstrates understanding of workflow prioritization. Education: BS/MS/Doctorate degree in Pharmacy or Nursing, or related discipline or comparable field of study from an accredited college or university. Experience: minimum 5 years of Pharmacovigilance or Materiovigilance experience, preferably in individual case review. Experience managing direct reports within a regulated industry (medical devices, pharmaceuticals). Experience with regulatory inspections and preparedness. Willing to work in US time zones when required Signature: Prepared by: Date: Approved by: Signature: Date This position may be available in the following location(s): IN - Gurgaon 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. [IF APPLICABLE] For U.S. locations that require disclosure of compensation, the starting pay for this role is between [$000,000.00 and $000,000.00] [or $00.00 - $00.00 per hour]. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. [SHOULD BE INCLUDED WITH PAY TRANSPARENCY LANGUAGE IN THE PARAGRAPH ABOVE IF APPLICABLE] U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation. Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Bausch + Lomb's Job Offer Fraud Statement. Our Benefit Programs: Employee Benefits: Bausch + Lomb Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.