Pharmacovigilance Specialist- Bausch & Lomb
Pharmacovigilance Specialist- Bausch & Lomb
Bausch & Lomb
Job description
Interested in a career in safety and regulatory compliance? Check out this Pharmacovigilance Specialist job opportunity with Bausch + Lomb in Mumbai for supporting case quality, adverse event reporting & safety compliance.
Company Description
Bausch & Lomb is a multinational eye health firm dedicated to protecting and enhancing the gift of sight. It has a portfolio of more than 400 items backed by research, development, production and commercial operations. Now, the company employs about 13,000 people and operates in approximately 100 countries, offering solutions for eye health to patients around the world.
Job Summary
The Pharmacovigilance Specialist will do quality evaluation of Individual Case Safety Reports (ICSRs) and medical device occurrences. Responsibilities include adverse event processing, expedited regulatory reporting, post-marketing surveillance, safety documentation and Medical Affairs support. The Pharmacovigilance Specialist works with vendors, regulatory teams, CROs and distributors. They maintain procedures, trains people, supports audits and helps assure compliance to Indian and global pharmacovigilance requirements.
Key Responsibilities
Vendor Oversight and Quality Review: Review vendor processed Individual Case Safety Reports (ICSRs) and medical device events, assess the quality of cases, answer medical issues and assure compliance with business processes and international regulations.
Pharmacovigilance and Regulatory Reporting: Accept, record, handle and report adverse events, pharmaceutical mistakes and pregnancy instances. Report expedited ICSR reports to the applicable regulatory authorities and keep necessary follow-up documents.
Post-Marketing Surveillance: Coordinate post-marketing surveillance programs, manage CRO activities, create or review study protocols and reports and support regulatory submissions.
Medical-Device Safety Reporting: Prepare and submit medical-device adverse-event and safety-information reports by mandated deadlines; maintain correct records and collaborate with internal and external stakeholders.
Medical Affairs, Training and Compliance: Support medical information services, examine promotional materials, design and maintain standard operating procedures (SOPs), teach staff and vendors, and assist with audits, inspections, and corrective and preventative actions (CAPA).
Educational Qualification
A Bachelor's degree in a related discipline, or a comparable field of study from an accredited college or university.
At least 3 years of experience in pharmacovigilance, or post-marketing surveillance within the pharmaceutical industry or a medical environment.
Experience in individual case safety report review or medical-device event review is preferred.
Skills Required
Knowledge of drug safety reporting, adverse event management, and applicable regulatory requirements.
Experience with safety databases (LSMV and CatsWeb are preferred systems).
Knowledge of general medicine or pharmacy, clinical practice, scientific terms and medical terms.
Excellent written, verbal and interpersonal communication skills with the ability to work collaboratively with internal teams, vendors and regulatory stakeholders.
Attention to detail, organizational skills, ability to prioritize workflow, strategic planning and project-management skills.
Salary Structure
The average salary of Pharmacovigilance Specialist at Bausch and Lomb in Mumbai ranges between ₹6 Lakhs to ₹8 Lakhs per year.
Career Development
This role as a Pharmacovigilance Specialist develops competence in medication safety, medical device vigilance, regulatory reporting and post marketing surveillance. It can also improve your abilities in quality assurance, compliance, vendor management and Medical Affairs, which can lead to future pharmacovigilance leadership, safety operations and regulatory affairs roles.
How to Apply
Open our job portal. Search for Pharmacovigilance Specialist- Bausch & Lomb listing.
Review the full job information and check the eligibility conditions.
Fill out the application form.
Upload your resume consisting of relevant experience in pharmacovigilance, adverse-event reporting and safety database.
Submit your application.
Education
Bachelor's Degree
Key Skills
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