Samria Aslam
Drug Safety Project Manager @Labcorp
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WORK HISTORY
Drug Safety Project Manager @Labcorp
Provide leadership and management of global and regional pharmacovigilance projects ensuring that communications and processes are harmonized for assigned projects• Manage compliance with safety reporting in accordance with international reporting regulations and SOPs• Work closely with the Clinical Operations and Project Management groups to ensure all pharmacovigilance activities are performed according to the regulatory and contractual requirements• Generate aggregate reports (e.g. DSURs and 6-month SUSAR line listings) ensuring data quality meets the global regulatory compliance standards for assigned projects• Prepare Safety Management Plans and reconciliation plans ensuring optimal efficiency• Provide oversight of timely pharmacovigilance reports for products and safety issues including ICSRs, SAEs and aggregate reports• Generate monthly status reports ensuring the quality and accuracy of metrics and data provided• Attend regular client meetings and liaise with clients as appropriate • Solve operational problems of project members • Provide pharmacovigilance project training for assigned projects to project members • Functional lead representative for internal and client audit for assigned projects• Generation and execution of CAPAs• Reviewing and providing key input into Safety Data Exchange Agreements
EDUCATION
Royal Holloway, University of London
Bachelor's degree, Biomedical Sciences, General
ABOUT SAMRIA ASLAM
Drug Safety Project Manager
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