Manami Tarafdar
Bengaluru
Summary
Results-driven Safety and Pharmacovigilance associate with ~7 years of industry expertise, possessing in-depth knowledge of Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), and ICH guidelines. Efficiently manages ICSR case processing, submission, quality assurance, and leads activities of clinical trials. Demonstrates a precise and systematic approach, quick learning ability, and collaborative nature. Committed to utilizing expertise in PV to ensure the highest standards of safety and compliance in the pharmaceutical industry. Demonstrates proficiency in problem-solving and project management. Known for reliability and strong focus on achieving objectives.
Overview
7
7
years of professional experience
Work History
Operations Specialist 1
IQVIA RDS (India) Pvt. Ltd.
06.2022 - Current
- Oversaw day-to-day operations, delegating tasks and allocating cases appropriately to ensure smooth workflow and timely completion of projects.
- Performed Lead Activities for Study Start-up and Maintenance phases that include: Project specific safety management plan (SMP) and SMP associated document review, Client alignment meeting conduction, Safety Database set up based on the study requirement.
- Organized safety training ensuring appropriate training for the project team members and preparing slide decks for the required trainings.
- Performed monthly review of distribution lists, quarterly monitoring of SSARs, Non-serious AEs and SAE reconciliation.
- Boosted customer satisfaction, addressing client concerns in a timely and professional manner.
- Successfully managed multiple projects simultaneously while adhering to deadlines and budget constraints.
- Provided input and details when involved in CAPA/QI process while adhering to the internal response timelines set for resolution/escalation process
- Provided training and sessions to a team of 75 about process knowledge, newly implemented processing updates, and CAPA implementation.
- Reviewed cases entered for quality, consistency, and accuracy (QC certified within 6 months).
- Delivered Safety Management Department Services according to ICH-GCP timelines, regulatory requirements and IQVIA's SOPs and/or project specific procedures.
- Processed reporting of incoming safety events and related data from different phases of clinical trials from multiple clients and MAHs.
- Query generation, following up and tracking out of reports, and report submission.
- Performed quality review and processing of all clinical trial ICSRs for client specific investigational products on but not limited to the following therapeutic areas: Infectious disease (e.g Meliodosis), Oncology (e.g.: Prostate cancer, Multiple myeloma, Advanced solid tumors, Myelofibrosis, Glioblastoma, NSCLC, Breast Cancer etc.), Musculoskeletal disease, Metabolic Diseases (e.g.: Diabetes Mellitus), Cardiac Disorders (e.g.: Supraventricular tachycardia), Neurology (e.g.: Peripheral Neuropathy), Gastroenterology (e.g.: Ulcerative colitis).
- Promoted a culture of accountability within the department by setting clear expectations for performance and holding team members responsible for achieving results.
- Provided training for new hires, cross-trained tenured associated in role transition, fostering a supportive learning environment conducive to success in their roles.
- Facilitated team meetings to encourage collaboration and share best practices across organization.
Safety and PV Specialist
Syneos Health (Inventive International Pharma Services Pvt. Ltd.)
10.2020 - 06.2022
- Conducted quality review of Individual Case Safety Reports (ICSRs) and manage all aspects of case processing, including triage, data entry, quality review, safety submissions to health authorities.
- Provided subject matter expertise on pharmacovigilance processes, including RCA and CAPA writing, and manage SharePoint for efficient information sharing.
- Performed quality management and KPI analysis, driving continuous improvement in processes.
- Exercised judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listed-ness.
- Reviewed, processed, and submitted all serious and non-serious ICSRs received from Clinical trials, post marketing phase, spontaneous cases, and Product Quality Complaints (PQC) from unsolicited sources.
- Following up with sites regarding outstanding queries possessing strong inter-personal skills to communicate with the client
- Developed training materials to enhance staff proficiency and productivity.
- Trained and mentored new associates, enhancing team capabilities to ensure high-quality outputs.
Junior Data Analyst
Cognizant Technology Solutions
01.2018 - 10.2020
- Managed core case processing of Individual Case Safety Reports (ICSRs) based on internal policies, procedures and departmental SOPs, ensuring compliance with regulatory standards and timelines while assessing validity and data accuracy.
- Performed initial triage of received source documentations in Siebel Safety Database, determined whether they are Product Technical Complain (PTC) or Product Quality Complaint (PQC) or an Adverse Event (AE) report from different sources as follows: Solicited reports including Patient support and disease management programs, Market research studies and Patient use programs; Unsolicited or Spontaneous reports including social media reports; Reports of suspected adverse reactions from scientific and medical literature and Legal department.
- Hands on expertise on the following as a Regulatory Submission reviewer (Reporting Officer for US-FDA):
1. Investigational New Drug (IND)
2. New Drug Application (NDA)
3. Abbreviated New Drug Application (ANDA)
4. Biologic License Application (BLA) - Managed the import and rejection through E2B gateway and E2B pending screen reconciliation.
- Mitigated potential risks by proactively identifying inconsistencies or errors within datasets and cases, addressing issues before they impacted project outcomes or timelines.
- Analyzed RCA, recommended corrective actions and investigated RCA for LDF submissions as well.
- Communicated closely with client and management for the completion of tasks, adhered to the expected turnaround time for reporting workflow to maintain the crucial regulatory submission timeline.
- Conducted quality hurdles, presented team in Audit inspection.
Education
Master of Science - Human Physiology
University of Calcutta
Kolkata01.2017
Bachelor of Science - Human Physiology
University of Calcutta
Kolkata01.2015
Skills
- Pharmacovigilance Expertise, Knowledge of ICH-GCP
- ICSR Case Management
- Quality Management
- Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) Management
- Subject Matter Expert
- Clinical Trial Lead Activities
- Regulatory Compliance
- Workflow Management and optimization
- Pharmacovigilance Tools: Oracle- Argus
- Rave EDC (iMedidata)
- MedDRA Coding, WHO Drug Dictionary (WHODD) Coding, Company Drug Dictionary (CDD) coding
- Software Proficiency: MS Office
- Problem-solving abilities
- Emotional intelligence
- Teamwork and collaboration
- Excellent Oral and Written communication skills
Skillsandachievements
- Recognized in IQVIA Impact Programme for delivering a high important presentation to the team of 75 associates including CAPA implementation that led to exceptional quality improvement of the team fetching excellent client satisfaction.
- Qualified for Study-lead role within a year of employment in IQVIA.
- QC qualified within 6 months of joining for outstanding quality of ICSR processing in Syneos Health.
- Ensured 100% compliance with no late submissions to health authorities while streamlining ICSR processes during the transition from pilot to operational phase for new drugs.
- Achieved ~99.5% quality KPI for category 1 errors, exceeding the threshold of 96%, and maintained a 100% KPI for the overall case field level.
- Recognized for exemplary focus on performance excellence and for rising above as a swift learner in Cognizant.
Disclaimer
I, Manami Tarafdar, hereby declare that the information furnished above is true to best of my knowledge.
Timeline
Operations Specialist 1
IQVIA RDS (India) Pvt. Ltd.
06.2022 - Current
Safety and PV Specialist
Syneos Health (Inventive International Pharma Services Pvt. Ltd.)
10.2020 - 06.2022
Junior Data Analyst
Cognizant Technology Solutions
01.2018 - 10.2020
Master of Science - Human Physiology
University of Calcutta
Bachelor of Science - Human Physiology
University of Calcutta
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