Looking to advance your career in pharmacovigilance quality? PrimeVigilance is hiring an Operational Quality Officer for its ICSR Management Department. This full-time opportunity is based in Pune, Maharashtra, with remote working flexibility, making it an excellent option for experienced pharmacovigilance professionals seeking quality and compliance roles.
Candidates with 2โ3 years of pharmacovigilance experience, including at least 2 years of ICSR processing and prior exposure to Quality or Compliance, are encouraged to apply.
Job Details
| Particular | Details |
|---|---|
| Position | Operational Quality Officer |
| Company | PrimeVigilance |
| Department | ICSR Management |
| Location | Pune, Maharashtra, India |
| Work Mode | Remote / Work From Home Eligible |
| Employment Type | Full-Time |
| Experience Required | 2โ3 Years |
| Qualification | Biomedical Sciences Degree or Relevant Experience |
About PrimeVigilance
PrimeVigilance is a globally recognized pharmacovigilance organization dedicated exclusively to drug safety, regulatory compliance, and patient safety. Operating across Europe, North America, South America, Asia, and Australia, the company supports pharmaceutical and biotechnology organizations throughout the complete product lifecycleโfrom clinical development to post-marketing surveillance.
The company emphasizes quality, continuous improvement, collaboration, and innovation while maintaining a patient-first approach.
Key Responsibilities
As an Operational Quality Officer, you will be responsible for driving quality initiatives and maintaining inspection readiness across the pharmacovigilance department.
Major responsibilities include:
- Manage departmental deviations and CAPAs.
- Support Subject Matter Experts (SMEs) in conducting root cause analysis.
- Ensure timely closure of corrective and preventive actions.
- Coordinate audit and inspection CAPA preparation.
- Maintain departmental audit and inspection readiness.
- Analyze quality data to identify improvement opportunities.
- Conduct department-specific quality training sessions.
- Organize interview practice sessions for audits and inspections.
- Assist in developing quality training materials.
- Prepare quality and compliance metrics.
- Collaborate with departmental leadership to enhance quality performance.
Required Qualifications
Applicants should possess:
- University degree in Biomedical Sciences or equivalent relevant experience.
- 2โ3 years of Pharmacovigilance experience.
- Minimum 2 years of ICSR processing experience (mandatory).
- Previous experience in Quality Assurance or Compliance within pharmacovigilance.
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication skills.
- Good planning, organizational, and multitasking abilities.
- Ability to work independently and collaboratively.
Preferred Skills
Candidates with the following skills will have an advantage:
- Electronic Quality Management System (eQMS) experience
- CAPA Management
- Root Cause Analysis
- Audit Readiness
- Inspection Support
- Quality Metrics Reporting
- Pharmacovigilance Compliance
- Advanced Microsoft Office skills
- Team collaboration
- Time management
Why Join PrimeVigilance?
PrimeVigilance offers professionals the opportunity to work on global pharmacovigilance projects while contributing to patient safety worldwide.
Employee Benefits
- Remote working flexibility
- International work environment
- Career growth opportunities
- Exposure to global pharmacovigilance quality systems
- Collaborative culture
- Continuous learning and professional development
- Work on regulatory inspections and quality excellence initiatives
Who Should Apply?
This role is ideal for:
- Pharmacovigilance Associates
- Senior Drug Safety Associates
- ICSR Specialists
- Pharmacovigilance Quality Professionals
- Quality Compliance Executives
- Drug Safety Officers with Quality experience
How to Apply
