Experience

C4 Therapeutics, Inc.

• United States
• Biotechnology
• 1 - 100 Employee

• Senior Pharmacovigilance Operations Specialist

  • May 2023 - Present



EMD Serono, Inc.

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Local Patient Safety Associate

  • Mar 2018 - Present

  •Collection, assessment and interpretation of adverse event information to ensure global reporting obligations. Independently analyze and question data to determine appropriate course of action to meet regulations. •Oversight of vendor handling local safety information including collection, registration and transmission to GPS as applicable in a timely manner •Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous… Show more •Collection, assessment and interpretation of adverse event information to ensure global reporting obligations. Independently analyze and question data to determine appropriate course of action to meet regulations. •Oversight of vendor handling local safety information including collection, registration and transmission to GPS as applicable in a timely manner •Seeking comprehensive initial and follow-up information on Individual Case Safety Reports (ICSRs) from all relevant spontaneous sources, and (where applicable) of cases from local interventional and non-interventional studies, Patient Data Collection Systems (PDCS) and quality complaints that are combined with adverse event information in a timely manner •Ensuring global literature search strategy is in accordance with GPS procedures and local requirements •Collaboration with medical information, quality assurance, complaint management and PDCSs to ensure safety reporting procedures are in place, safety relevant information is processed in a timely manner, and reconciliation is completed •Keeping product knowledge up-to-date to ensure appropriate Individual Case Safety Report (ICSR) handling •Performing required safety activities in the absence of the Manager; Local Patient Safety Office •Oversight and at least annual review of automatic post-marketing distribution rules to FDA •Using applicable tools (e.g. IRT) to ensure local compliance in terms of ICSR handling according to local regulations and company timelines •Contributions to the Local PV file under the supervision of the Associate Director Compliance in close collaboration with cross-functions to support completeness, accuracy and that relevant information is updated in a timely manner •Supporting the Associate Director Compliance in keeping a complete overview of local / global clinical studies and PDCS (planned as well as ongoing) in the US

• Drug Safety Analyst

  • Oct 2015 - Mar 2018



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Technologist III

  • Apr 2013 - Oct 2015

  Provides clinical and bioanalytical testing support for post-market studies of Fabrazyme® and clinical trial programs of sphingolipid and glycolipid biomarkers using LC/MS/MS methods conforming to GLP/GxP practices. Responsible for the analysis and data reconciliation for over 10 biomarkers associated with lysosomal storage diseases. Contributes to the writings of periodic trial phase reports summarizing current data findings. Originates and participates in crossover studies of critical… Show more Provides clinical and bioanalytical testing support for post-market studies of Fabrazyme® and clinical trial programs of sphingolipid and glycolipid biomarkers using LC/MS/MS methods conforming to GLP/GxP practices. Responsible for the analysis and data reconciliation for over 10 biomarkers associated with lysosomal storage diseases. Contributes to the writings of periodic trial phase reports summarizing current data findings. Originates and participates in crossover studies of critical reagents and validation studies of developed clinical assays. Responsible for the procurement of all laboratory supplies and the maintenance of group’s critical reagent inventory. Performs maintenance, calibration, and troubleshooting of LC/MS/MS platforms. Show less Provides clinical and bioanalytical testing support for post-market studies of Fabrazyme® and clinical trial programs of sphingolipid and glycolipid biomarkers using LC/MS/MS methods conforming to GLP/GxP practices. Responsible for the analysis and data reconciliation for over 10 biomarkers associated with lysosomal storage diseases. Contributes to the writings of periodic trial phase reports summarizing current data findings. Originates and participates in crossover studies of critical… Show more Provides clinical and bioanalytical testing support for post-market studies of Fabrazyme® and clinical trial programs of sphingolipid and glycolipid biomarkers using LC/MS/MS methods conforming to GLP/GxP practices. Responsible for the analysis and data reconciliation for over 10 biomarkers associated with lysosomal storage diseases. Contributes to the writings of periodic trial phase reports summarizing current data findings. Originates and participates in crossover studies of critical reagents and validation studies of developed clinical assays. Responsible for the procurement of all laboratory supplies and the maintenance of group’s critical reagent inventory. Performs maintenance, calibration, and troubleshooting of LC/MS/MS platforms. Show less



Ensemble Therapeutics

• Associate Scientist

  • Jun 2012 - Apr 2013

  Performs synthesis of bioconjugates of oligonucleotides and small organic molecules. Conducts purification and analysis of nucleic acid bioconjugates using semi-preparative HPLC and LC/MS prior to DNA Programmed Chemistry of the formation of macrocycles. Performs organic coupling reactions of small molecule linkers to oligonucleotide templates. Gives weekly presentations to research group illustrating current status of macrocycle library building and progress of optimization research. Performs synthesis of bioconjugates of oligonucleotides and small organic molecules. Conducts purification and analysis of nucleic acid bioconjugates using semi-preparative HPLC and LC/MS prior to DNA Programmed Chemistry of the formation of macrocycles. Performs organic coupling reactions of small molecule linkers to oligonucleotide templates. Gives weekly presentations to research group illustrating current status of macrocycle library building and progress of optimization research.



Massachusetts General Hospital

• Research Technician

  • Feb 2010 - Jun 2012

  Assisted in the development and validation of analytical methods to measure anticancer drugs in biological matrices by HPLC with conventional detection and various LC/MS techniques for early phase clinical trials. Used validated analytical methods to assay samples for metabolism and pharmacokinetic studies. Maintained findings in scientific notebook and composed data reports. Prepared analytical stocks, working solutions, mobile phases, and pretreatment of biological samples. Performed routine… Show more Assisted in the development and validation of analytical methods to measure anticancer drugs in biological matrices by HPLC with conventional detection and various LC/MS techniques for early phase clinical trials. Used validated analytical methods to assay samples for metabolism and pharmacokinetic studies. Maintained findings in scientific notebook and composed data reports. Prepared analytical stocks, working solutions, mobile phases, and pretreatment of biological samples. Performed routine calibration and maintenance of analytical instrumentation. Show less Assisted in the development and validation of analytical methods to measure anticancer drugs in biological matrices by HPLC with conventional detection and various LC/MS techniques for early phase clinical trials. Used validated analytical methods to assay samples for metabolism and pharmacokinetic studies. Maintained findings in scientific notebook and composed data reports. Prepared analytical stocks, working solutions, mobile phases, and pretreatment of biological samples. Performed routine… Show more Assisted in the development and validation of analytical methods to measure anticancer drugs in biological matrices by HPLC with conventional detection and various LC/MS techniques for early phase clinical trials. Used validated analytical methods to assay samples for metabolism and pharmacokinetic studies. Maintained findings in scientific notebook and composed data reports. Prepared analytical stocks, working solutions, mobile phases, and pretreatment of biological samples. Performed routine calibration and maintenance of analytical instrumentation. Show less



US Army

• United States
• Armed Forces
• 700 & Above Employee

• Staff Sergeant

  • Aug 1995 - Feb 2006

  Served as a Senior Healthcare Specialist responsible for the primary and emergency medical care of a unit with over 100 assigned personnel. Routinely triaged, diagnosed, and treated soldiers seeking medical aid under the guidance of the unit’s Medical Officer. Maintained patient medical records, procurement and inventory of medical supply, and enforced protocol and practices consistent with JCAHO compliance. Also served as a Squad Leader responsible for the training, readiness, and well-being… Show more Served as a Senior Healthcare Specialist responsible for the primary and emergency medical care of a unit with over 100 assigned personnel. Routinely triaged, diagnosed, and treated soldiers seeking medical aid under the guidance of the unit’s Medical Officer. Maintained patient medical records, procurement and inventory of medical supply, and enforced protocol and practices consistent with JCAHO compliance. Also served as a Squad Leader responsible for the training, readiness, and well-being of six subordinate medics. Show less Served as a Senior Healthcare Specialist responsible for the primary and emergency medical care of a unit with over 100 assigned personnel. Routinely triaged, diagnosed, and treated soldiers seeking medical aid under the guidance of the unit’s Medical Officer. Maintained patient medical records, procurement and inventory of medical supply, and enforced protocol and practices consistent with JCAHO compliance. Also served as a Squad Leader responsible for the training, readiness, and well-being… Show more Served as a Senior Healthcare Specialist responsible for the primary and emergency medical care of a unit with over 100 assigned personnel. Routinely triaged, diagnosed, and treated soldiers seeking medical aid under the guidance of the unit’s Medical Officer. Maintained patient medical records, procurement and inventory of medical supply, and enforced protocol and practices consistent with JCAHO compliance. Also served as a Squad Leader responsible for the training, readiness, and well-being of six subordinate medics. Show less