Puneet Chauhan

Experience

• 

  Quantum Solutions India

  Sept 2012 - Mar 2015

  ☛ Conducted quality reviews of spontaneous cases, including serious and non-serious cases, clinical studies, literature cases, and recall cases, ensuring adherence to standard operating procedures (SOPs) and reporting timelines prior to submission to regulatory authorities.☛ Maintained a comprehensive understanding of the adverse event safety profiles of assigned drugs/class of drugs, reference safety information documents, data entry conventions, guidelines, client procedures, and international drug safety regulations.☛ Performed consistency checks on cases for labeling and other relevant parameters.☛ Managed the team during crisis situations, prioritizing cases and ensuring compliance with internal and regulatory timelines for adverse event reporting.☛ Generated reports for daily work allocation to team members, monitored team productivity on a daily basis, and coordinated with managers regarding team output.☛ Trained and mentored drug safety associates on Individual Case Safety Reports (ICSRs) management. Show less ☛ Managed Individual Case Safety Reports (ICSRs) of various case types, including spontaneous, E2B, clinical studies, legal cases, licensee partner cases, literature cases, and solicited programs.☛ Made critical decisions and conducted initial assessments to determine whether to enter cases into the drug safety database, including running duplicate searches for previously reported cases.☛ Conducted medical and regulatory assessments of drug safety data, evaluating seriousness, monitoring adverse events, coding events using MedDRA, and labeling events according to the Company Core Data Sheet.☛ Wrote case narratives in chronological format and performed quality checks/E2B checks on processed cases before reporting to regulatory authorities to ensure accurate data reporting and maintain patient confidentiality.☛ Performed follow ups with clinical study investigators, health care professionals, affiliates for drug safety related correspondences.☛ Involves working on various therapeutic areas namely, Oncology, Bio-surgery/ Renal products, Genetic disorders/ Personalized genetic health products, Metabolic disorders, Cardiovascular, Endocrine, Immunology/Autoimmune diseases, Medical devices and Hematology. Show less

  • Pharmacovigilance Analyst

    Apr 2014 - Mar 2015

  • Pharmacovigilance Scientist

    Sept 2012 - Mar 2014
• 

  Parexel

  Apr 2015 - now

  ☛ Performing routine signal detection activities on client safety database, regulatoryauthority database, literature articles and regulatory authority websites.☛ Lead authoring of assessment of identified signals by medical analysis of case series, targeted literature search, review of data from internal PV database and external PV databases, medical textbooks and clinical databases to create the documentation detailing the safety signal.☛ Lead authoring of specified sections of client safety deliverables such as Periodic Benefit-Risk Evaluation Report (PBRER) or Risk Management Plan (RMP).☛ Support the preparation and maintenance of safety sections of labeling as well as draft responses for health hazard evaluations.☛ Support the preparation of presentations of safety data and related information for product safety leads and safety governance committees.☛ Support the preparation of responses to health authority safety requests.☛ Manage Safety Information Tracking System for signals, targeted medical events of interest and health hazard evaluations.☛ Training and mentoring of the PV scientists on signal management process. Show less ☛ Conducted routine signal detection activities on a monthly, quarterly, bi-annual, and annual basis, employing both qualitative and quantitative methods to identify potential safety signals.☛ Executed ad hoc signal detection activities, utilising established statistical signal detection methods to estimate signal significance.☛ Managed signals for assigned products on EudraVigilance through the EudraVigilance Data Analysis System (EVDAS), accessing electronic Reaction Monitoring Reports, Line Listing Reports, and Individual Case Safety Reports (ICSRs) forms via EVDAS and EVWEB.☛ Demonstrated in-depth understanding and experience in causality assessment while conducting signal management activities.☛ Submitted signal information to specified National Competent Authorities in accordance with their requirements.☛ Conducted data mining activities in collaboration with the global product safety lead for signal management, facilitating signal detection and evaluation. Show less ☛ Monitored compliance investigation tool adherence by tracking standardised ICSR lateness reasons and implementing corrective and preventive actions as necessary.☛ Conducted quality reviews of all types of Individual Case Safety Reports (ICSRs) and recall cases, ensuring adherence to SOPs and timelines.☛ Analysed error and lateness trends identified during compliance monitoring activities.☛ Managed client interactions regarding compliance investigations, collaborating with client's quality counterparts for data analysis and process enhancement.☛ Assumed the role of acting backup for the team manager, handling team member queries in their absence.☛ Participated in the recruitment of new drug safety associates for the pharmacovigilance operations team alongside team managers. Show less

  • Principal Medical Writer

    Apr 2022 - now

  • Senior Pharmacovigilance Specialist

    Apr 2018 - Mar 2022

  • Pharmacovigilance Specialist

    Apr 2015 - Mar 2018