Experience

Corcept Therapeutics

• United States
• Biotechnology Research
• 200 - 300 Employee

• Safety Medical Director

  • Sep 2022 - Present



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Medical Director II

  • Jun 2021 - Oct 2022



Pharmacyclics, an AbbVie Company

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Associate Medical Director I

  • Jan 2018 - Jun 2021



Indivior

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Medical Advisor

  • Mar 2015 - Jan 2018

  Current role is involve three major activities: Signal Detection & Risk Management: Review of monthly literature articles for company products from post marketed surveillance and Investigator Initiated Trials, to identify the safety concern. Review biweekly Fatality Reports product quality complaints. Review of Global Safety database Preferred Terms which crosses threshold and perform signal validation activity. Development of Safety Signal and Medical Analysis reports. Prepare Safety Expert Report for special request from regulatory agencies. Review of Pre-clinical studies. Review of PSUR, PBRER, DSUR, and PADER Prepare the Summary of Safety Information for annual IND reports. Medical Monitor & Safety Surveillance of Clinical Trials: Provide 24/7 coverage for any safety concern in Clinical Trials. Review of the clinical trials data (Adverse Events line listing) on monthly basis. Prepare CML (Close Monitoring List) for the investigational drug of each clinical trial and keep close monitoring for those events. Attend the monthly medical monitoring call and Ad hoc discussion with sites to discuss the safety information for ongoing clinical trials. Review of the SMP (Safety Management Plan) and Safety TFLs. Review of the submission documents like CSR (Clinical Study Report) and Integrated safety summary (ISS Prepare Quarterly Safety Review Report for clinical trials to identify any safety concern in clinical study. Prepare Adhoc Safety Expert Report for any clinical trial challenges or regulatory agency concern. Medical Review of an ICSR: Medical review of ICSR and providing assessment of seriousness, expectedness, listedness, relatedness for all the serious and non-serious adverse events. Maintenance of Medical Evaluation Convention tracker for assist in case processing activities. Providing guidance to PV specialist and other Medical Advisors for ongoing Global PV activities. Show less



Valeant Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigilance Scientist

  • Jan 2015 - Mar 2015

  • Performed quality/ medical review of individual case safety reports, including coding, seriousness, expectedness and causality assessment for assigned therapeutic areas. • Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment. • Responsible for signal detection activity and analysis of data search results for assigned products. • Informed Medical Director for safety related issues or potential trends and/ or signals. • Performed medical query search and analysis on case by case basis for AE and SAE to correlate medical sense and interpretation of the data in the safety database. • Communicated with partner companies, collaborative sponsors and their respective clinical research organizations (CROs) regarding the evaluation and processing of case reports. • Reviewed and provided inputs of medical/pharmacovigilance content and clinical relevance to regulatory safety documents including IB, PEBER, PSURs, Risk Management Plan and ad hoc regulatory reports. • Analyzed metrics for critical Drug Safety processes to ensure compliance with SOPS and regulatory requirements. • Developed and maintained SDEA and PV agreements with business partners, ensuring that company standards are upheld and international safety regulations are met. • Worked closely with PV Physician and PV Associate director in analyzing and organizing the workflow and processing refinement for global adverse events. Show less



MMS

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Drug Safety Associate/ Team Lead

  • Jan 2014 - Nov 2014

  • Worked as a drug safety team lead for multiple narratives and case processing projects for different clients. • Reviewed adverse event reports within approved timelines as defined in local and global work instructions, SOPs and regulations to meet local and global reporting requirements. • Assisted Medical monitor/ Safety physician in safety and medical monitoring of clinical trials. • Represented company’s Drug safety department in Investigator meeting for clinical trials. • Provided oversight and guidance to Pharmacovigilance and Project Management teams regarding adverse event case management for clinical studies. • Performed Quality Review of ICSR’s for accuracy and completeness of MedDRA coding, seriousness, expectedness, data entry, and narrative. • Performed cumulative safety data review and safety surveillance activities to review for potential safety signals, and write summary report for suspected signal event with the template provided. • Performed SAE reconciliation to check the discrepancy between clinical and safety database. • Performed Medical/ Quality review of Clinical Study Report (CSR) narratives. • Monitors Safety database for multiple clinical trials and helped team to achieve all milestones within defined timeline. • Reviewed coding of adverse events using MedDRA and timely advance cases through Safety Database workflow within global and local timelines. • Conducted review and assessment of case reports in respect of Quality of documentation, Casualty Assessment, Clinical Relevance and Quality control. • Reviewed deliverables prior to releasing to client. • Assisted Compliance group to create and maintain tracking of compliance reports and plans and helped in creating Corrective action & preventing action (CAPA) for team. Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Safety Associate

  • Jul 2012 - Mar 2013

  • Reviewed and evaluated adverse event forms for completeness and validity using medical knowledge and experience. • Performed a review of ancillary documentation accompanying adverse event reports and identifies pertinent clinical information to enter into company’s drug safety database. • Prepared cases in ARIS agExchange (IRT) and gIRA databases (Company’s database). • Processed initial and follow-up information for both serious and non serious adverse events in safety database followed by writing an event description (Narrative) using company’s template. • Performed quality review to ensure completeness and accuracy of data entered into the safety database. • Performed coding for adverse events using MedDRA, suspect drug using company dictionary, and concomitant medications using WHO dictionary. • Daily contacts with the physicians and health care providers to confirm the adverse events. • Performed the follow ups with reporters via eFax, email, and telephone. Track report progress using ARISg database. Initiate and complete quality checks of adverse event cases. • Processed follow-up receipt into the gIRA for workflow tracking and initiating associated tasks like follow-up report prep, address queries, interfacing with USPV to update the follow up receipt. • Worked on reconciliation for coded information in gIRA and the cumulative listing from IRT Receiver Unit to ensure the consistency. Show less