Are you passionate about patient safety and quality in the pharmaceutical industry? Navatio Pharma Solutions is hiring a Quality Assurance Pharmacovigilance (PV) Specialist in Hyderabad for an exciting full-time role. This position offers a unique opportunity to ensure compliance with global regulatory standards while making a meaningful impact on pharmacovigilance processes. If you’re an immediate joiner with expertise in PV and quality assurance, this is your chance to shine!
Key Responsibilities
As a Quality Assurance Pharmacovigilance Specialist, you will play a critical role in maintaining the highest standards of pharmacovigilance activities. Your responsibilities include:
- QA Oversight: Oversee all pharmacovigilance activities, including adverse event (AE) reporting, signal detection, risk management, and regulatory compliance to ensure patient safety.
- Audits and Inspections: Plan and conduct internal and external audits to ensure compliance with Good Pharmacovigilance Practices (GVP), FDA, EMA, ICH, and WHO regulations.
- Documentation Review: Review and approve safety-related documents like case narratives and reports for accuracy and regulatory compliance.
- Regulatory Compliance: Stay updated on global pharmacovigilance regulations and ensure adherence to local and international standards.
- CAPA Management: Identify non-compliance issues and implement Corrective and Preventive Actions (CAPAs) to improve processes.
- Training and Support: Train internal teams and clients on pharmacovigilance quality assurance best practices and regulatory requirements.
- Continuous Improvement: Recommend process enhancements based on industry trends and regulatory changes.
- Collaboration: Work with clinical, regulatory, and medical affairs teams to integrate quality assurance in PV activities.
- Client Management: Act as the primary point of contact for clients on quality assurance and PV compliance matters.
Qualifications
To excel in this role, candidates should meet the following requirements:
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or a related field.
- Experience: 3-5 years of experience in pharmacovigilance, with at least 2 years in a quality assurance or audit role within the pharmaceutical or CRO industry.
- Skills: Strong knowledge of GVP, FDA, EMA, ICH, and WHO regulations; expertise in auditing, CAPA management, and PV documentation.
- Attributes: Detail-oriented, proactive, excellent communication skills, and ability to work in a fast-paced environment.
Benefits
Joining Navatio Pharma Solutions offers:
- Opportunity to work in a dynamic, patient-focused environment.
- Competitive salary (INR 8,00,000 – 12,00,000 per annum, depending on experience).
- Professional growth through continuous learning and training.
- Collaborative and innovative workplace culture in Hyderabad.
How to Apply
Ready to make a difference in pharmacovigilance? Send your CV to hr@navatiopharma.com with the subject line “QA Pharmacovigilance Specialist Application.” Immediate joiners are preferred, so apply today to secure this exciting role!
