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Alliance Compliance Expert

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Improve compliance with global Pharmacovigilance agreements by regular compliance analysis, reporting and communication, including corrective action oversight, monitoring and verification of database configuration requirements, maintenance of other accurate listings and assistance in agreement maintenance/updates.Major Accountabilities (HR Core IT9102 ST9002) 1.Compliance Organises and analyses compliance data for safety information exchange with global license partners and provides root cause analyses for individual cases submitted late to authorities and other non-compliance with global pharmacovigilance agreements. 2.Reconciliation - ensures regular reconciliation of exchanged reports between Novartis & global licensing parties is performed & documented. Communicates any reconciliation issues to PAM, PAH and PPV Head and liaises with PAM to resolve internally and with the license partners. 3.Authors monthly compliance and reconciliation reports, including trend-analyses, for exchange of individual case reports, and other written safety documents between global licensing parties, for both incoming and outgoing information. 4.Alerts PAM; PAH and PPV Head, EU-QPPV and DS&E Operations Management of compliance and reconciliation issues and liaises with PAM, PAH, global operations, DS&E management and license partners to ensure that corrective actions proposed and implemented by the operations groups / license partners are appropriate and effective to improve and maintain a high level of compliance. 5. Argus configuration - regularly reviews expediting requirements and organises verification of corresponding Argus configuration in collaboration with PV-SDM and PAM, as required. 6.Pharmacovigilance agreement updates updates and maintains with PAM, global pharmacovigilance agreements as required.Key Performance Indicator(s) (HR Core IT9102 ST9003) Effective monitoring of Novartis compliance (timeliness/completeness) for case exchange specified in global license agreements Effective monitoring of license partner compliance (timeliness/completeness) for case exchange specified in global license agreements Root cause analyses completed for all late cases from license partners. Analyses for late cases from license partners resulting in late health authority submissions provided to PPV team for inclusion in quarterly compliance reports Timeliness and quality of monthly license partner compliance reports generated and distributed to PVO managements and license partners. Effective communication of issues, recommendations for remediation and monitoring of corrective actions. Root cause analysis of late cases from Novartis to license partners completed for specified products/case types
Degree: MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: MBBS

Experience: 2-6


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