Pharmacovigilance Specialist

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.

BAUSCH + LOMB 2.1.1-NTEM-1 Template Revision: 4 TITLE: Job Description Template Page 1 of 4 Job Description Job Title Senior Pharmacovigilance Specialist– Medical Affairs, India Business Title Vendor QC Associate, Pharmacovigilance and Materiovigilance – Medical Affairs, India Band Business Unit / Function Global Pharmacovigilance and Risk Management (GPRM) / R & D (Medical Affairs) Job Code Location Gurgaon, India Objectives / Purpose of the Job The role will be responsible for directly engaging with the case processing vendor to ensure that case processing work performed by the vendor is of high quality and compliance, and to improve the quality and compliance of ICSR reporting and device events. The role 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. In addition, the role will:  Support Medical Affairs Operations and Functions  Pharmacovigilance (PV) for Drugs and Quasi drugs  Post-Marketing Surveillance for New drugs (Re-examination)  Safety Information Reporting for Medical Devices Key Activities / Responsibilities Vendor Oversight and Case Quality Review  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.  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.  Work cross functionally with other members of the department to ensure high quality cases and work efficiency with vendor delegated tasks.  Formulate and implement improvements as needed. Pharmacovigilance (PV) for Drugs and Quasi drugs  Represent B+L India as the ‘PV designee’ and comply with the responsibilities of the ‘PV designee’ in accordance with the local regulation.  Prepare safety reports (Adverse Events, Medication errors and pregnancy cases obtained through spontaneous, literature and all other potential sources) via receiving, documentation, reporting to BAUSCH + LOMB 2.1.1-NTEM-1 Template Revision: 4 TITLE: Job Description Template Page 2 of 4 the global function, data-entry to the global database, follow-up and archiving.  Perform expedited reporting of Individual Case Safety Reports (ICSRs) to the local regulatory agency in accordance with local regulatory requirements.  Review relevant sections of Data Exchange Agreements as applicable to case processing, and manage Pharmacovigilance agreements with 3rd party distributors to ensure AE reporting compliance. Post-Marketing Surveillance for New drugs (Re-examination)  Ownership of any PMS program (if applicable) and key liaison point for other functions – Regulatory Affairs, Medical Affairs & Clinical Operations.  Oversee CRO’s activities for PMS studies based on SOP, protocol and regulation in cooperation with Clinical Operations.  Prepare/review study documents such as protocols, CRFs, Periodic Reports and Re-examination Application (final report) and be responsible for local regulatory submission.  Report SAE cases to the CDSCO, India and the Global function. Safety Information Reporting for Medical Devices  Prepare Adverse Event reports for medical devices via receiving, documentation, data-entry to the global database, follow-up and archiving.  Submit Adverse Event reports and Safety Information reports as required by the local regulatory agency within timelines. Medical Affairs Operations  Support MSA activities across all products and BUs.  Conduct promotional material review for B+L marketed products.  Medical Information Services – provide medical information to internal/external customers on B+L products upon request, with responses to medical inquiries falling within the approved labeling.  Manage ECP / HCP podium speaker suitability review & tier evaluation.  Manage KOLs to generate data (posters, abstracts, publications) to support new products.  Work with KOLs to develop medical education programs to support B+L on key treatment areas / products. SOPs and Training  Develop and revise local SOPs (PV, PMS and Safety Information Management) to ensure compliance with local regulatory agency requirements and global/regional PV SOPs.  Participate in the creation, implementation and update of global/regional vigilance SOPs, Work Instructions and vendor procedures as needed, and support other global projects. BAUSCH + LOMB 2.1.1-NTEM-1 Template Revision: 4 TITLE: Job Description Template Page 3 of 4  Train and provide guidance on drug safety reporting to vigilance and vendor support staff, all new employees and all B+L India employees on a periodic basis, employees participating in PMS studies (if applicable), and third-party distributors. Incoming Vigilance Inspections / External Vigilance Audits  Support any vigilance audit or inspection and ensure readiness at all times, including preparation of documentation for presentation during vigilance audits and inspections, and coordination and facilitation of regulatory agency inspections and corporate audits for PMS studies. Non-Conformances/Deviations and CAPA documents  Interact with the compliance team to ensure necessary corrective and preventive actions have been taken to ensure case processing compliance, and assist with preparation of Non Conformances/Deviations and CAPA documents related to vendor oversight. Correspondence and Archive  Maintain the internal and external correspondence within the defined duties and activities.  Archive PV/vigilance and PMS related documents according to company processes and local regulatory requirements.  Perform any other vigilance related activities as assigned. Supervise Direct Reports (yes or no) No Scope of Position e.g. • Sales volume responsibility • Budget responsibility • Size of team • Sites (General information for the 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. Represents B+L India as local PV designee and supports Medical Affairs operations, Post-Marketing Surveillance (Re-examination) and medical device safety information reporting across all products and BUs. Reports to the Vendor and Site Manager. Key Relationships (e.g., internal customers/business partners, external customers/partners)  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 / Clinical Operations  Quality Department / Quality Assurance  Customer Service  Sales Department  Finance BAUSCH + LOMB 2.1.1-NTEM-1 Template Revision: 4 TITLE: Job Description Template Page 4 of 4  Marketing  R&D  Management Representative  External customers (patients, health care professionals, including ECPs and KOLs)  External partners (distributors, business partners, Vendor(s) including CROs)  Health authorities, including CDSCO, India Qualifications / Training (e.g., professional qualifications, on-the-job training, education, experience) Knowledge/Skills: Global safety, pharmacovigilance, and materiovigilance regulations and guidelines; Use of safety database, preferably LSMV and CatsWeb; Sound knowledge of general medicine or pharmacy and clinical practice, with 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; Strategic planning & project management; 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, Materiovigilance or Post Marketing Surveillance experience in the pharmaceutical industry or medical environment, preferably in individual case or device event review. Prepared by: [Name, Title] Signature: Date: Approved by: [Name, Title] Signature: Date:

This position may be available in the following location(s): IN - Mumbai

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 US 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.