Ipsita Bhattacharjee

• Conduct case intake and triage for incoming safety information from various sources.
• Processed adverse event data by entering safety information into tracking systems.
• Managed narrative writings for marketed products, coding adverse events effectively.
• Assist in the listedness assessment against the appropriate label for marketed products
• Assisted in generating queries and collecting missing or discrepant information.
• Submission of expedited SAE reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, Partners as required within the agreed timelines.
• Processed and submitted expedited and periodic reports to global regulatory agencies, ethics committees, investigators, and other recipients.
• Assist in the reconciliation of databases, as applicable.
• Operated within the Quality Management System framework, including Standard Operating Procedures and departmental Work Instructions.
• Maintained supporting files and documentation for adverse event reporting requirements globally.
• Facilitated proper storage and upload of various documentations including cases, studies, and projects.
• Cultivated strong PSS relationships across functional units.
• Ensured adherence to regulatory standards.
• Completed necessary tasks beyond primary responsibilities.

Key Indications Managed:

• Post-Marketing Study Programs: Myasthenia gravis, and Chronic inflammatory demyelinating polyneuropathy.
• Clinical Trial Programs: Immune Thrombocytopenic Purpura, Bullous Pemphigoid, Sjögren's Syndrome, Membranous Nephropathy.

• Key responsibilities: case assessment, MedDRA coding, SAE narrative writing, assessing causality, seriousness and expectedness/ listedness of adverse events in reference safety information, prioritizing based on timelines and quality reviewing of ICSR.
• Processing of Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• 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.
• Coding AE and Products, writing narratives, related activities as per internal/ project timelines.
• Ensuring to meet quality standards per project requirements.
• Ensuring to meet productivity and delivery standards per project requirements.
• Ensuring compliance to all project related processes and activities and required training are executed in a timely fashion.
• Creating, maintaining and tracking cases as applicable to the project plan.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• Identify quality problems, if any, and bring them to the attention of a senior team member.
• May liaise with client in relation to details on day-to-day case processing activities.
• To mentor and peer review new team members when assigned by the Manager.
• Attend project team meeting and provide feedback to operations manager on any challenges/issues or successes.
• Perform other ad hoc activities such as case closure, query response and other as assigned.
• Lead/Support department initiative.
• 100% compliance towards all practice and process.

Key Indications Managed:

• Post-Marketing Study Programs: Rheumatoid arthritis, Crohn's disease, metastatic cancer, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, psoriasis, uveitis, metastatic cancers.