Quality Assurance Pharmacovigilance (PV) Specialist Full Time

Navatio Pharma Solutions is seeking a Quality Assurance Pharmacovigilance (PV) Specialist. If you're passionate about ensuring patient safety and delivering top-quality results, this is your chance to make a lasting impact.

Position Summary : The Quality Assurance (QA) Pharmacovigilance Specialist will be responsible for ensuring the highest quality standards in pharmacovigilance activities provided to our clients. The role involves overseeing and auditing pharmacovigilance systems, processes, and data to ensure compliance with regulatory requirements, internal SOPs, and industry best practices.

• QA Oversight : Lead the quality assurance processes for all pharmacovigilance activities, including adverse event (AE) reporting, signal detection, risk management, and regulatory compliance.
• Audits and Inspections : Plan, conduct, and report on internal and external audits of pharmacovigilance activities to ensure compliance with Good Pharmacovigilance Practices (GVP), local and global regulations, and company standards.
• Documentation Review : Review and approve safety-related documents, including case narratives, reports, and analysis, to ensure completeness, accuracy, and consistency.
• Regulatory Compliance : Monitor and ensure compliance with global regulatory requirements (FDA, EMA, ICH, WHO, etc.) related to pharmacovigilance and safety reporting.
• CAPA Management : Identify areas of non-compliance or improvement opportunities and lead the development and implementation of Corrective and Preventive Actions (CAPAs) to address quality issues.
• Training & Support : Provide training to internal teams and clients on pharmacovigilance quality assurance best practices, regulatory requirements, and company procedures.
• Continuous Improvement : Stay updated on regulatory changes and industry trends and proactively recommend improvements to processes and systems to enhance pharmacovigilance quality.
• Collaboration : Collaborate with cross-functional teams (clinical, regulatory, medical affairs) to ensure seamless integration of quality assurance across all pharmacovigilance activities.
• Client Management : Serve as the primary point of contact for clients regarding quality assurance concerns and provide expert guidance on PV compliance issues.

Join us and be a part of a dynamic team ensuring patient safety worldwide! Apply now or refer a suitable candidate! Email your resume to: : hr@navatiopharma.com