Senior 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 worldfrom 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

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.

Prepared by:

Signature:

Date:

Approved by:

Signature:

Date

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

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.

Prepared by:

Signature:

Date:

Approved by:

Signature:

Date

This position may be available in the following location(s): [[location_obj]]