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.
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