PrimeVigilance, part of the Ergomed Group, has announced an exciting opportunity for an Operational Quality Officer in Pune, Maharashtra, India. This full-time pharmacovigilance quality role is ideal for professionals with 2โ3 years of pharmacovigilance experience, including at least 2 years of ICSR processing, and prior experience in Quality or Compliance.
If you have expertise in CAPA management, deviation handling, audit readiness, pharmacovigilance quality systems, and ICSR compliance, this PrimeVigilance Operational Quality Officer job offers an excellent opportunity to work with a globally recognized pharmacovigilance organization while contributing to patient safety.
Job Details
| Particular | Details |
|---|---|
| Position | Operational Quality Officer |
| Company | PrimeVigilance (Ergomed Group) |
| Department | ICSR Management |
| Job Type | Full-Time |
| Location | Pune, Maharashtra, India |
| Work Mode | Remote Eligible |
| Experience | 2โ3 Years |
| Qualification | Biomedical Sciences degree or relevant experience |
| Industry | Pharmacovigilance |
Key Responsibilities
As an Operational Quality Officer, you will:
- Manage deviations and CAPAs within the department.
- Support Subject Matter Experts (SMEs) in conducting Root Cause Analysis (RCA).
- Ensure timely completion of CAPA actions.
- Coordinate audit and inspection CAPA preparation.
- Drive departmental audit and inspection readiness.
- Analyze quality data to support continuous improvement initiatives.
- Deliver quality and compliance training programs.
- Organize audit interview preparation with SMEs.
- Develop departmental quality training materials.
- Prepare quality and compliance metrics.
- Collaborate with Quality teams and department leadership to improve operational excellence.
Eligibility Criteria
Educational Qualification
- Bachelor’s or Master’s degree in Biomedical Sciences or equivalent relevant qualification.
Experience Required
- 2โ3 years of Pharmacovigilance experience
- Minimum 2 years of ICSR Case Processing experience (Mandatory)
- Previous experience in Quality Assurance or Compliance is required.
Required Skills
- Pharmacovigilance Operations
- ICSR Processing
- CAPA Management
- Deviation Management
- Root Cause Analysis (RCA)
- Audit Readiness
- Inspection Readiness
- Quality Compliance
- Electronic Quality Management Systems (eQMS)
- MS Office
- Planning & Time Management
- Technical Documentation
- Team Collaboration
- Excellent Written & Verbal English
Why Join PrimeVigilance?
PrimeVigilance offers employees the opportunity to work with global pharmaceutical companies while maintaining high standards of patient safety.
Benefits include:
- Remote work flexibility
- Global career exposure
- International pharmacovigilance projects
- Collaborative work culture
- Continuous professional development
- Learning and training opportunities
- Diverse international teams
- Strong quality-focused environment
Salary (Estimated)
Based on similar Pharmacovigilance Quality roles in India:
Estimated Salary: โน8,50,000 โ โน13,00,000 per annum (CTC)
Actual compensation may vary depending on experience, skills, and company policies.
How to Apply
