Senior Pharmacovigilance Specialist Job at Bausch + Lomb – Apply Now
Looking for exciting Pharmacovigilance Jobs with strong career growth? This Senior Pharmacovigilance Specialist role at Bausch + Lomb offers an excellent opportunity in Risk Management Jobs, ensuring quality oversight, compliance excellence, and leadership in ICSR and device event reporting within Global Pharmacovigilance and Materiovigilance operations.
Job Details
- Job Title: Vendor QC Associate, Pharmacovigilance and Materiovigilance
- Location: Mysore, India
About the Company
Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing vision for millions worldwide. With 400+ products, 13,000 employees, a presence in nearly 100 countries, and a 170-year legacy, the company is a trusted leader known for innovation, quality, and patient safety.
Job Description
The Vendor QC Associate will directly engage with the case processing vendor to ensure high-quality, compliant case processing while improving ICSR reporting and device event quality. This includes organizing and performing quality reviews according to global regulations and company procedures while supporting strong Pharmacovigilance and Risk Management operations.
Key Responsibilities | Pharmacovigilance Jobs
- Ensure work performed by the vendor is of high quality and in 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 the 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 guide vigilance and other support staff for the vendor.
- Formulate and implement improvements as needed.
- Interact with the 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 ensure relevant archiving of vigilance documentation if needed.
Incoming vigilance Inspections/External vigilance Audits
- Assist with the preparation of documentation for presentation during vigilance audits and inspections. Ideal for Risk Management Jobs
Non-Conformances/Deviations and CAPA documents
- Assist with the 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.
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 Required for Pharmacovigilance Jobs
Knowledge & Skills
- Strong knowledge of global Pharmacovigilance & Materiovigilance regulations
- Experience with LSMV, CatsWeb, and safety databases
- Excellent communication and documentation skills
- Strong attention to detail
- Team collaboration capability
Education:
- Doctorate in Pharmacy, 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.
