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Quality Assurance Pharmacovigilance (Pv) Specialist

2-5 years
Not Disclosed
10 Dec. 20, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Exciting Career Opportunity: Quality Assurance Pharmacovigilance Specialist at Navatio Pharma Solutions

Job Title: Quality Assurance Pharmacovigilance (PV) Specialist
Location: Hyderabad
Job Type: Full-Time

Position Summary:
Navatio Pharma Solutions is looking for a dedicated Quality Assurance Pharmacovigilance (PV) Specialist to oversee and audit pharmacovigilance activities, ensuring compliance with regulatory standards and internal SOPs. If you're passionate about patient safety and quality assurance, this is your opportunity to make an impact.

Key Responsibilities:

  • 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 and execute internal and external audits of pharmacovigilance activities to ensure compliance with Good Pharmacovigilance Practices (GVP), local and global regulations.
  • Documentation Review: Review and approve safety-related documents, ensuring completeness, accuracy, and consistency.
  • Regulatory Compliance: Ensure compliance with global regulatory requirements (FDA, EMA, ICH, WHO, etc.) related to pharmacovigilance and safety reporting.
  • CAPA Management: Identify non-compliance areas and lead the development of Corrective and Preventive Actions (CAPAs) to address quality issues.
  • Training & Support: Provide training to internal teams and clients on PV quality assurance best practices and regulatory requirements.
  • Continuous Improvement: Stay updated on regulatory changes and industry trends to proactively improve pharmacovigilance quality.
  • Collaboration: Work with cross-functional teams (clinical, regulatory, medical affairs) to integrate quality assurance in pharmacovigilance activities.
  • Client Management: Serve as the primary contact for clients regarding PV compliance issues and provide expert guidance.

Qualifications:

  • Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine, or related field.
  • Experience: Minimum of 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.

Interested?
Please send your CV to hr@navatiopharma.com.

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