Scientific Affairs Associate | Novartis Pharmaceuticals Australia & New Zealand

Job Details:
DescriptionTo execute and manage Sandoz Pharmacovigilance & Clinical Safety operations on local level and support management of Sandoz Global Pharmacovigilance & Clinical Safety (GPV&CS) operational processes in ensuring compliance with internal Sandoz global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance regarding Sandoz marketed and investigational products. Provide scientific advice and information to both internal and external queries to ensure the prompt provision of accurate scientific and medical information and pharmacovigilance of Sandoz products. Provide training and coaching of staff in the protocols and expected performance applicable to pharmacovigilance.
1. Execute collection, processing, documentation, reporting and follow- up of all ad-verse event (AE) reports and adverse drug reactions (ADR) for all Sandoz prod-ucts from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, commercial programs, etc. 2. Ensure recording and tracking of receipts/submissions/distributions of Individual Case Safety Reports (ICSR), Serious Adverse Events (SAEs), Investigator Notifi-cations (IN), Periodic Safety Report Updates (PSUR) and ensure report-ing/submission/distribution of safety reports/updates/information (e.g. ICSR, SAE, IN, PSUR, changes in risk benefit) to local Health Authorities (HA) according to regulatory requirements. 3.Work with other local/global PV associates to ensure accurate processing of safe-ty data. 4. Interact and exchange relevant safety information with local HA, PV associates, other functional groups and third party contractor, if applicable. 5.Survey and monitor national pharmacovigilance regulations and provide update to GPV & CS. 6. Set up, implement and update local procedures to ensure compliance with GPV & CS procedures, Global Medical Information procedures and national require-ments. 7. If applicable, coordinate execution/implementation of Risk Management Plans/Commitments and ensure related documentation. 8. Process literature cases detected locally. 9. Review safety sections of all local non-interventional study protocols and review the contract (SSW) if a Contract Research Organisation (CRO) is conducting the trial, train the CRO associates responsible for the trial. 10. Review marketing program proposals regarding correct terminology, content and establishment of necessary flow of information and control on collection and re-porting of adverse event information as part of Patient Oriented Programs (POPs). Train responsible vendor associates. 11. Assure reconciliation is performed with other departments (e.g. Medical Infor-mation, Call Center, Quality Assurance and third party contractor, if applicable) for potential ADRs/AEs resulting from medical inquiries and quality related com-plaints. 12.Management and maintenance all local relevant PV databases. 13. Ensure timely preparation and submission of KPI reports on ADR/AE and PSUR reporting including identification of root cause(s) for internal and external late reporting inclusive of development and implementation of corrective/preventive action(s) as needed. 14. Develop and update training
Minimum requirementsGraduate in medical science, veterinary medicine, pharmacy, biology, biochemistry or similar discipline - Fluent in both written and spoken English..
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