Tamara Kahn Email & Phone Number

Australia

Sydney, New South Wales, Australia

- Deputy Pharmacovigilance Country Safety Head for Australia and New Zealand at Sanofi- Operational Lead for local day-to-day PV operations- People management- Development and ongoing management of local RMPs (ASA and additional risk minimisation activities)- Local SDEA and PVA creation. Management of PV activities relating to acquisitions and divestments.- Signal detection and reporting in accordance with AU and NZ regulations. Signal review for local products.- TGA inspection and audit experience

- Key point of contact for Oncology TA PV system activities, including the review and approval of Organised data collection programs, creation of PV contracts, PSUR and DSUR review, clinical studies oversight.- Product safety monitoring for Oncology TA products including review of local data for safety signals.- Review of Oncology TA RMPs and assisting in creation of the ASA.- Review and tracking of incoming regulatory intelligence and escalation as required.- Communication and tracking of Oncology SSIs to local stakeholders.- Generation and communication of monthly product metrics.- Compassionate supply review and approver for on-label PBS requests.- General PV tasks including triage and HA reporting

- Reviewed the current SDV framework and assessed feasibility for the reduction in scope, including comprehensive review of GVP guidelines.- Planned and delivered a Pilot for reducing the requirement for SDV for US ODC programs- Assessed the implications for company-wide roll out for reduced SDV frequency- Involved in assessing the potential for outsourcing various Global ODC operations- Input for Global ODC audit CAPAs- Drafted guidelines and recommendations for reducing the requirement for SDV

Sydney, Australia

- Collaboration and engagement with internal stakeholders including BI and Marketing, as the main contact for all Organised Data Collection (ODC) programs, currently in the Immunology therapeutic area, including review, entry and maintenance of the ODC databases.- Main point of reference for consultation and advice on PV responsibilities for ODC programs to ensure compliance with both internal and external policy.- Identification and escalation of potential PV resource for implementation of new programs at the local affiliate and escalation of safety concerns as required to Head of PV.- Management and oversight of vendor PV compliance, including periodic compliance monitoring, and provision of training where required.- Collaboration with global and regional PV colleagues to promote best practise sharing and increase understanding in the ODC space.- Provision of weekly updates on ODC at the PV management review meetings.- Coordination of ODC related PVA contracts and management within the PVA contracts database.- Oversight of PV impact assessments on all Local PV documents.- General PV activities including case processing in accordance with company and health authority governance.

Responsibilities:- Back up point of contact and provision of support for the Interim Head of PV.- Assisted in making management decisions on case processing, ODC governance and metrics.- Responsible for managing 5 direct reports, including holding regular 1:1 catch ups and ensuring reports management needs were met.- Daily management of team, including re-allocation of tasks per workload, ensuring open communication channels with team members, presenting to the business on ODC requirements and maintaining current workload.- Attending Regional PV meetings on a regular basis.

Sydney, Australia

Newly created role as part of the Medical Affairs Operations department, primarily focused on Risk Management Plans (RMPs).- RMP receipt and creation/update of Australian Specific Annexe (ASA)- Implementation and tracking of all additional commitments in Australia as detailed in RMP and ASA.- Cross functional collaboration with regards to RMP commitments across all therapeutic areas.- PSUR tracking and submissions- Impact assessment for all MAFOPs documents- Ad hoc PV duties including triage, case processing and HA reporting.- Project work

Sydney, Australia

Triage, case processing and local health authority reporting of all local investigational and marketed products.PSUR CFI response coordination and submission of PSURs to TGA and Medsafe.Implementation and tracking of CARMAs.Creation and submission of several Australian Specific Annexes (ASAs) to accompany submission of EU-RMP to TGA.Subject matter expert for DS process. Owner of associated SOPs and WIs.Review and impact assessment of global policy documents.

High Wycombe

High Wycombe

Horsham

Master'S Degree, Human/Medical Genetics, Distinction

2.1 Bsc (Hons) Biology And Forensic Science, Biology And Forensics