Thermo Fisher Scientific is inviting applications for the position of Quality and Training Specialist – Pharmacovigilance (PV). This fully remote Pharmacovigilance job in India is ideal for experienced Pharmacy and Life Sciences professionals with strong expertise in PV quality management, GPV compliance, audits, inspections, training, and quality systems.
The selected candidate will play a critical role in strengthening Pharmacovigilance operations by ensuring compliance with global regulatory requirements, conducting quality reviews, delivering training programs, supporting audits, and driving continuous process improvement initiatives.
For professionals seeking senior-level Pharmacovigilance Quality Assurance jobs in India, this opportunity offers exposure to global drug safety operations and regulatory compliance frameworks.
Key Responsibilities
Pharmacovigilance Training & Development
- Design and deliver onboarding and refresher training programs for PV project teams.
- Develop training plans and compliance learning materials.
- Mentor team members and support capability development initiatives.
Quality Management & Compliance
- Conduct real-time quality review of Pharmacovigilance deliverables.
- Perform trend analysis and identify quality gaps.
- Recommend corrective and preventive actions (CAPA) through targeted training interventions.
- Support development and reporting of GPV compliance metrics.
SOP & Documentation Management
- Create, review, and update SOPs, work instructions, and project-specific guidelines.
- Ensure documentation remains aligned with regulatory and client requirements.
- Maintain procedural consistency across projects.
Audits & Inspections
- Support internal and external Pharmacovigilance audits.
- Assist during regulatory inspections and follow-up activities.
- Prepare audit responses and remediation plans.
- Ensure inspection readiness across assigned projects.
Process Improvement
- Lead quality-related escalation activities.
- Collaborate with cross-functional teams, CROs, and vendors.
- Drive continuous improvement initiatives for PV operations.
- Present quality trends and recommendations to stakeholders.
Required Qualifications
Educational Qualification
- Bachelor’s Degree in Pharmacy, Life Sciences, or related discipline.
- Master’s Degree preferred.
Experience Requirements
- Minimum 7+ years of Pharmacovigilance experience.
- At least 5+ years of experience in PV Quality Assurance roles.
- Proven experience supporting audits, inspections, and GPV compliance programs.
- Experience with risk-based quality systems and process improvement initiatives.
Required Skills
Candidates should possess:
- Strong knowledge of global Pharmacovigilance regulations.
- Expertise in FDA, ICH, CDSCO-PvPI, EU GVP, and PMDA guidelines.
- Experience in Quality Management Systems (QMS).
- Strong stakeholder management and communication skills.
- Audit and inspection readiness expertise.
- Knowledge of drug safety databases and regulated electronic systems.
- Learning Management Systems (LMS) experience.
- Documentation management and compliance reporting skills.
Why Join Thermo Fisher Scientific?
Working as a Quality and Training Specialist – Pharmacovigilance offers several advantages:
- Fully remote work opportunity across India.
- Exposure to global Pharmacovigilance operations.
- Career growth within a leading life sciences organization.
- Involvement in international audits and inspections.
- Opportunity to lead training and quality excellence initiatives.
- Collaborative work environment with global stakeholders.
Salary Information
Based on current industry benchmarks for senior Pharmacovigilance Quality professionals in India, the expected salary range is:
₹18 LPA – ₹28 LPA (depending on experience, skills, and interview performance).
How to Apply
