• Responsible for standard surveillance activities for a product’s life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and the literature• Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sourcesAnalyzes data to support signal assessment and contributes to ad hoc regulatory safety requests using… Show more • Responsible for standard surveillance activities for a product’s life cycle (one or more assigned compounds and products) through review of safety data from clinical trials, safety databases, and the literature• Collaborates with safety and clinical teams to develop strategies and approaches for signal assessments and regulatory requests by analyzing data from multiple sourcesAnalyzes data to support signal assessment and contributes to ad hoc regulatory safety requests using data from multiple sources with supervision• Utilizes medical judgment to determine the impact of identified safety issues on the compound/ product’s benefit-risk profile• Communicates findings of surveillance activities and safety assessments to product teams and leadership to inform on necessary risk minimization activities, including label changes• Collaborative preparation and maintenance of safety sections of Clinical Summary of Safety, Clinical Study Reports, Company Core Data Sheets and Risk Management Plan• Support strategy development, authorship and review of global aggregate safety reports in accordance with regulatory requirements and standard operating procedures with supervision• Prepares summaries of key safety data for PST, SRB, senior management, Advisory and other similar meetings with supervision• Proficient in pharmacovigilance regulations, guidelines, and company standard operating procedures• In depth understanding of compounds within assigned therapeutic areas, including safety profile and where applicable, labeling, literature, clinical and regulatory issues Show less

Project: Therapeutic utility of targeting the nuclear receptor coregulatory interactome with peptidomimetics in hormone-dependent cancers-Assessed the efficacy of peptidomimetics in various models including in vitro, in vivo and prient derived explant tissues as monotherapy or in combination with other chemotherapeutic drugs.-Established the molecular mechanisms of these compounds using unbiased mass spectroscopy and whole genome sequencing.

Project 1: Interrelationships among SELENOF genotype, cellular localization, serum selenium and race in prostate cancer. I genotyped functional polymorphisms and examined the interactions between SELENOF genotype, serum selenium and race in a Chicago area cohort of men who had undergoneprostatectomy. I analyzed levels and cellular location of SELENOF in cultured cells by western blotting and confocal microscopy as well as in human tissue microarrays by immunohistochemistry scored by… Show more Project 1: Interrelationships among SELENOF genotype, cellular localization, serum selenium and race in prostate cancer. I genotyped functional polymorphisms and examined the interactions between SELENOF genotype, serum selenium and race in a Chicago area cohort of men who had undergoneprostatectomy. I analyzed levels and cellular location of SELENOF in cultured cells by western blotting and confocal microscopy as well as in human tissue microarrays by immunohistochemistry scored by computer-assisted image analysisProject 2: Role of SELENOF in the normal prostate. I examined the morphological and biological effects of SELENOF shRNA knockdown in 2D cultures and prostate organoids using normal prostate cells and normal transformed RWPE1 prostate cell line. Show less

Project 1: Gene-Gene interaction between antioxidant enzymes glutathione peroxidase 1 (GPX1) andmanganese superoxide dismutase (MnSOD). I investigated the molecular interaction between polymorphic variants of GPX1 and MnSOD, manipulated the genotypes of GPX1 and MnSOD in MCF-7 human breast cancer cell lines, and assessed whether the allele-specific interactions altered the levels of proteins implicated in cancer etiology.Project 2: Cellular location of selenoproteins in human… Show more Project 1: Gene-Gene interaction between antioxidant enzymes glutathione peroxidase 1 (GPX1) andmanganese superoxide dismutase (MnSOD). I investigated the molecular interaction between polymorphic variants of GPX1 and MnSOD, manipulated the genotypes of GPX1 and MnSOD in MCF-7 human breast cancer cell lines, and assessed whether the allele-specific interactions altered the levels of proteins implicated in cancer etiology.Project 2: Cellular location of selenoproteins in human prostatic tissue and association with prostatecancer recurrence. I assessed whether the levels and cellular location of GPX1 and selenoprotein F (SELENOF) are associated with prostate cancer recurrence using prostate cancer tissue microarrays. Show less