Pharmacovigilance Jobs at Opella – Apply Exclusively on Rasayanika
Job Title: Pharmacovigilance Case Quality Oversight Expert
Company: Opella
Location: Hyderabad / Mumbai (Remote/Hybrid flexibility as per business needs)
Experience Required: Minimum 5 Years in Pharmacovigilance
Industry Preference: Retail Health and Personal Care Products
Budget: Based on the previous CTC hike
Interview Rounds: Online
Role Overview:
We are seeking an experienced Pharmacovigilance Case Quality Oversight Expert who will be responsible for overseeing ICSR quality processes, ensuring compliance with regulatory requirements, and driving continuous process improvement across our case management operations.
Key Responsibilities:
• Monitor and ensure compliance in ICSR submissions, including deviation tracking and CAPA implementation.
• Perform Root Cause Analysis (RCA) for quality issues and drive effective CAPA strategies.
• Lead and contribute to quality review meetings, presenting findings and trends to internal stakeholders.
• Oversee vendor quality alignment and collaborate with cross-functional stakeholders (CSLs, License Partners).
• Drive improvement projects and lead process optimization initiatives for case management.
• Contribute to the development and revision of SOPs, job aids, and training materials.
• Ensure readiness and accuracy of documentation for inspections and audits.
• Maintain records of CAPAs, deviations, and effectiveness checks in accordance with QMS.
• Communicate case quality analytics effectively within the global PV community.
Required Skills & Experience:
• Proficient in PV databases (Argus, Aris-G/LSMV, Vault Safety)
• Strong knowledge of GVP, ICH, GxP, and global PV regulations
• Expertise in ICSR quality review, CAPA, RCA, and deviation management
• Experience with QMS and quality documentation
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