Quality and Training Specialist – Pharmacovigilance (PV)
Thermo Fisher Scientific is hiring a Quality and Training Specialist – Pharmacovigilance (PV) for a fully remote position in India. This opportunity is ideal for experienced Pharmacovigilance professionals with expertise in PV Quality Assurance, GPV Compliance, Audits, Inspections, Training Management, and Quality Systems.
📋 Job Overview
| Particulars | Details |
|---|---|
| Position | Quality and Training Specialist – Pharmacovigilance (PV) |
| Company | Thermo Fisher Scientific |
| Location | Remote – India |
| Employment Type | Full-Time |
| Experience | 7+ Years PV Experience |
| PV QA Experience | 5+ Years Preferred |
| Qualification | B.Pharm, M.Pharm, Pharm.D, BSc, MSc, Life Sciences |
🎓 Pharmacovigilance Training & Development
- Design onboarding and refresher PV training programs.
- Create compliance-focused learning materials.
- Develop training plans for project teams.
- Mentor team members and support capability development.
- Monitor training compliance and effectiveness.
🔍 Quality Management & Compliance
- Perform real-time quality review of PV deliverables.
- Identify quality gaps and compliance risks.
- Conduct trend analysis and quality monitoring.
- Recommend CAPA actions and improvement plans.
- Support GPV compliance metrics reporting.
📑 SOP & Documentation Management
- Create and update SOPs and work instructions.
- Review project-specific guidelines.
- Maintain regulatory-compliant documentation.
- Ensure consistency across PV projects.
🛡️ Audits & Inspection Support
- Support internal and external PV audits.
- Participate in regulatory inspections.
- Prepare audit responses and remediation plans.
- Maintain inspection readiness.
- Support quality governance activities.
⭐ Required Skills
- Global Pharmacovigilance Regulations
- EU GVP
- FDA Regulations
- ICH Guidelines
- CDSCO-PvPI Requirements
- PMDA Guidelines
- Quality Management Systems (QMS)
- CAPA Management
- Audit & Inspection Readiness
- Learning Management Systems (LMS)
🌟 Why Join Thermo Fisher Scientific?
- 100% Remote Work Opportunity.
- Exposure to global PV quality systems.
- International audits and inspections experience.
- Leadership exposure in PV compliance programs.
- Strong career growth opportunities.
- Work with global stakeholders and CRO partners.
🎓 Eligibility Criteria
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Related Healthcare or Scientific Discipline
- Minimum 7+ years of Pharmacovigilance experience
- At least 5+ years in PV Quality Assurance preferred
- Experience supporting audits, inspections, and compliance programs
💰 Salary Information
Based on current industry benchmarks for senior Pharmacovigilance Quality professionals in India, the expected salary range is:
₹18 LPA – ₹28 LPA
Actual compensation may vary based on experience, interview performance, PV QA expertise, and global compliance exposure.
📈 Career Path
- Drug Safety Associate
- Senior PV Associate
- PV Quality Specialist
- PV Quality & Compliance Lead
- Global Pharmacovigilance Manager
- Director – Drug Safety Quality
- Global Head – PV Quality & Compliance
📝 Resume Tips
- Highlight Pharmacovigilance Quality Assurance experience.
- Mention audit and inspection readiness activities.
- Include CAPA management and compliance metrics exposure.
- Showcase SOP development and training management experience.
- Mention EU GVP, FDA, ICH, CDSCO, and PMDA knowledge.
- Quantify quality improvement initiatives wherever possible.
🎯 Interview Preparation Tips
- Revise EU GVP modules and ICH guidelines.
- Review CAPA management processes.
- Understand inspection readiness requirements.
- Prepare examples of audit findings and resolutions.
- Review PV quality metrics and compliance reporting.
- Understand training effectiveness evaluation methods.
- Research Thermo Fisher's Pharmacovigilance services.
❓ Common Interview Questions
- What is Pharmacovigilance Quality Assurance?
- How do you prepare for a regulatory inspection?
- What is CAPA and how have you managed it?
- How do you identify quality trends in PV operations?
- What are key EU GVP requirements?
- How do you measure training effectiveness?
- Describe an audit finding you helped resolve.
- What quality metrics do you monitor?
- How do you ensure SOP compliance?
- Why do you want to join Thermo Fisher Scientific?
❓ Frequently Asked Questions (FAQ)
Q1. Is this a remote position?
Yes, this is a fully remote opportunity across India.
Q2. What experience is required?
Minimum 7+ years in Pharmacovigilance and preferably 5+ years in PV Quality Assurance.
Q3. Which qualifications are eligible?
B.Pharm, M.Pharm, Pharm.D, BSc, MSc, and related Life Sciences disciplines.
Q4. Is audit and inspection experience required?
Yes, experience supporting audits, inspections, and compliance programs is strongly preferred.
Q5. What is the expected salary range?
Approximately ₹18 LPA – ₹28 LPA depending on experience and expertise.
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