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.

- 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.

- 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.

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.

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.

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.

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.

High Wycombe

High Wycombe

Horsham

Master'S Degree, Human/Medical Genetics, Distinction

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