Quality Assurance Pharmacovigilance (PV) Specialist

Navatiopharma; Hyderabad; On-site; INR 700,000 - 900,000; Full time

Job summary

A leading pharmaceutical company in Hyderabad is seeking a Quality Assurance Pharmacovigilance Specialist. The role involves ensuring high standards in pharmacovigilance activities, overseeing audits, and guaranteeing compliance with regulatory requirements. Candidates should have 3-5 years of experience in pharmacovigilance and at least 2 years in a quality assurance role. This is a great opportunity for those passionate about patient safety and quality assurance in the pharmaceutical industry.

Qualifications

• Minimum of 3-5 years of experience in pharmacovigilance.
• At least 2 years in a quality assurance or audit role.
• Understanding of regulatory requirements for pharmacovigilance.

Responsibilities

• Lead quality assurance processes for pharmacovigilance activities.
• Plan and conduct internal and external audits of pharmacovigilance activities.
• Review and approve safety-related documents.
• Monitor compliance with global regulatory requirements.
• Identify areas for improvement and lead CAPA development.
• Provide training on quality assurance best practices.
• Recommend improvements to enhance pharmacovigilance quality.
• Collaborate with cross-functional teams.
• Serve as primary contact for clients regarding quality assurance.

Skills

Pharmacovigilance

Quality Assurance

Regulatory Compliance

CAPA Management

Client Management

Job description

Quality Assurance Pharmacovigilance (PV) Specialist FullTime

Roles : Minimum of 3-5 years of experience in pharmacovigilance,with at least 2 years in a quality assurance or audit role within thepharmaceutical or CRO industry.

Ready to Ignite your Career? We’re waiting for you!

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

Position Summary : The Quality Assurance (QA) Pharmacovigilance Specialist willberesponsible for ensuring the highest quality standards in pharmacovigilance activitiesprovided to our clients. The role involves overseeing and auditing pharmacovigilancesystems, processes, and data to ensure compliance with regulatory requirements, internalSOPs, and industry best practices.

Key Responsibilities

• QA Oversight : Lead the quality assurance processes for allpharmacovigilanceactivities, including adverse event (AE) reporting, signal detection, riskmanagement, and regulatory compliance.
• Audits and Inspections : Plan, conduct, and report on internal and externalauditsof pharmacovigilance activities to ensure compliance with Good PharmacovigilancePractices (GVP), local and global regulations, and company standards.
• Documentation Review : Review and approve safety-related documents,including casenarratives, reports, and analysis, to ensure completeness, accuracy, andconsistency.
• Regulatory Compliance : Monitor and ensure compliance with globalregulatoryrequirements (FDA, EMA, ICH, WHO, etc.) related to pharmacovigilance and safetyreporting.
• CAPA Management : Identify areas of non-compliance or improvementopportunities andlead the development and implementation of Corrective and Preventive Actions (CAPAs)to address quality issues.
• Training & Support : Provide training to internal teams and clients onpharmacovigilance quality assurance best practices, regulatory requirements, andcompany procedures.
• Continuous Improvement : Stay updated on regulatory changes and industrytrends andproactively recommend improvements to processes and systems to enhancepharmacovigilance quality.
• Collaboration : Collaborate with cross-functional teams (clinical,regulatory,medical affairs) to ensure seamless integration of quality assurance across allpharmacovigilance activities.
• Client Management : Serve as the primary point of contact for clientsregardingquality 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:: [e-mail]