Debanjana Mukherjee

Accomplished Senior Safety Science Specialist with a proven track record for enhancing workflow management and quality review processes. Expert in clinical trials case processing and mentoring, achieving a quality review percentage above 99%. Skilled in Veeva document management and SAE reconciliation, demonstrating a robust blend of technical prowess and leadership excellence. Results-oriented individual with a passion for continuous learning and innovation. Known for leveraging analytical thinking and creativity to solve problems and deliver high-impact solutions in fast-paced environments. Experienced in fast-paced environments and adaptable to last-minute changes. Thrives under pressure and consistently earns high marks for work quality and speed.

Senior Safety Science Specialist at Fortrea (Labcorp ), Bangalore- MAR 2023 to till date.
Safety Science Specialist at Labcorp (Covance), Bangalore- MAR 2021 to MAR 2023
Operations Specialist I at IQVIA, Bangalore – DEC 2017 to MAR 2021

Experience Summary:

• 6. 11 years of experience in pharmacovigilance and drug safety.
• Experience in coding of events, medical history by using MEDRA dictionaries.
• End to End Serious and Non-Serious Case Handling/Quality Review of legal, Spontaneous, Solicited and Clinical Trial cases.
• End to End Pharmacovigilance Experience in book in, triaging, Data Entry, Medical coding, Quality Review, Safety narrative, Finalization, Regulatory report generation as per timelines.
• To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information; determining initial/update status of incoming events; database entry; coding AE and Products, writing narratives.

Therapeutic Experience 

· Cardio Metabolic: Metabolic and Cardiovascular Risk - Hypertension (Phase IV)

· Immune Mediated Inflammatory Disease (IMID): Dermatologic - Psoriasis (Phase IV), Inflammatory Bowel - Crohn’s disease (Phase IV), Ulcerative colitis (Phase IV), Systemic IMID - Psoriatic arthritis (Phase IV), Ankylosing spondylitis (Phase IV)

· Oncology: Hematologic Malignancies – Multiple Myeloma (Phase IV)

· Hematology: Lymphoma – Follicular lymphoma (Phase II)

· Oncology: Lung Cancer – NSCLC (Non-Small Cell Lung Cancer Phase II

· Hematology: Plasma Cell Dyscrasias – Multiple Myeloma Phase II

· Hematology: Lymphoma – Diffuse large B cell lymphoma (DLBCL) Phase II and Phase IIIVaccine (Covid 19 Vaccine)

• Booster Drug (Vaccine)
• OTC Drugs

• Argus.6.0.7.8
• Argus 8.1.1
• ARISg
• PVCM
• MedDRA - For coding of Adverse Events, Medical History, Laboratory Data, properly searching the Low-Level Terms (LLT) from Low Level Terms Codes, Selecting the Proper Reaction Terms so that it can be mapped to correct System Organ Class (SOC).

• Workflow Management & Case Tracking:Efficiently manage and track the workflow of all cases, ensuring timely and accurate processing across various departments.
  Monitor case progress and handle case allocation through centralized and team-specific workflows.
  
• Central and Team Allocation:Oversee central allocation and ensure effective team allocation for optimal resource distribution and case handling efficiency.
  Track and report team performance, ensuring adherence to defined timelines and productivity goals.
  
• Hourly Tracking & Coordination:Conduct hourly tracking of case progress across various functional towers to ensure that all processes remain on schedule.
  Ensure seamless coordination between teams for case assignments and completions.
  
• Quality Review & Specialist Role:Perform quality reviews and provide specialized expertise across various towers, ensuring compliance with quality standards.
  Serve as a Subject Matter Expert (SME) for case processing, handling client queries, and addressing complex issues.
  
• Client Query Handling & Communication:Address client-related queries via calls and emails, providing timely and accurate responses to ensure client satisfaction.
  Facilitate communication between internal teams and clients to resolve issues and enhance service quality.
  
• New Joiner Certification & Training:Oversee the certification procedure for new joiners, ensuring they are properly trained and meet the necessary standards before assuming responsibilities.
  Conduct sessions for new joiners on client updates, process workflows, and internal database updates.
  
• Reconciliation & Case Review:Ensure proper reconciliation of data and case records to guarantee consistency and accuracy across platforms.
  Review individual case safety reports (ICSRs) for completeness and accuracy, ensuring they meet internal policies and regulatory requirements.
  
• Adverse Event (AE) Case Evaluation:Review and evaluate adverse event (AE) case information, determine required actions based on internal procedures, and ensure appropriate follow-up.
  Process all incoming AE cases to meet established timelines, ensuring timely reporting and resolution.
  
• Quality Assurance & Performance:Recognized as a top performer for maintaining a quality percentage above 99% in case reviews, contributing to the team's overall performance.
  Rewarded for consistent excellence in quality review and case management.
  
• Client & Database Updates:Take responsibility for conducting training sessions on new client updates and database changes to ensure all team members are aligned with current practices.
  Implement and drive new processes to improve quality control and reduce errors, preventing demotion and team quality degradation.
  
• ICH-GCP Compliance & Process Implementation:Ensure all processes comply with ICH-GCP (International Conference on Harmonisation - Good Clinical Practice) standards.
  Implement new processes and guidelines to improve case handling efficiency and quality outcomes.
  
• Coding & Safety Narrative:Responsible for coding medical histories, events, drugs, procedures, indications, and laboratory tests according to appropriate dictionaries such as MedDRA, WHODD, and company-specific product dictionaries.
  Write medically relevant safety narratives, ensuring the completeness and accuracy of the data entered into safety databases.
  
• PSUR & DSUR Knowledge:Possess in-depth knowledge of Pharmacovigilance Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR), ensuring accurate and compliant submissions.
  
• Data Integrity & Record Management:Ensure that two sets of records agree to prevent errors in case submissions and to avoid delays in case reporting.
  Maintain accurate records, ensuring timely submission of all cases in compliance with regulatory timelines.
  
• Reporting & Documentation:Manage end-of-day reports, including total closed case reports and central allocation data.
  Generate detailed reports on team and individual performance, ensuring transparency and alignment with project goals.
  

• Follow up with clients regarding outstanding queries.
• Responsible for reconciliation and workflow inflows on daily basis.
• Supported other projects on behalf of the customers.
• Training and mentoring for new employees.
• Preparation and execution of the action plan for comments and feedback given by client followed by MOM (Minutes of meeting) for every internal and customer meeting.
• Expert Panel POC, Deletion SME, PQC SME.

• "Supported global pharmacovigilance strategy by liaising with international teams, ensuring consistent safety reporting practices across regions and meeting diverse regulatory requirements."
• "Enhanced patient safety reporting processes, ensuring timely submission of all serious adverse event (SAE) reports to regulatory agencies, contributing to zero non-compliance citations during annual inspections."

Diploma In Clinical Research, NIDA Certification

I hereby declare that the above information provided is true to the best of my knowledge and belief.