Shweta Jadhav

1. Moderna project

Work exposure :

Database: Argus

• Case bookin and Triaging of drug and device cases to ensure prioritization and to comply with the regulatory requirement, search database to prevent duplicate entries and report nullification, to attach translation documents and mailbox handling.
• Moderna Vaccine

2. Samsung BI project

Work exposure:

Database: ArisG

• Case processing of serious and non serious PMS (post marketing surveillance) and solicited ICSRs.
• Full data entry including processing the patient data, adverse events reporting, Adverse event coding using Medraa, assessing the seriousness, Product coding using WHODD dictionary, Medical history coding, Narrative writing, causality and labeling assessment of the events according to the company core data sheet (CCDs) and country specific RSI documents.
• Handling of Medical Device cases (injections, infusions, syringes and Pens of respective products).
• Rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis and etc product cases (company specific).
• Bookin and triage of cases as per priority and timeline for some time.

3. Novo Nordisk Project

Work exposure :

Database: Argus, SIMS (safety intake management system) and CCGlow (Costumer complaints global workflow)

• Handling of Medical Device cases (Pens of respective products).
• Full data entry of safety only, technical complaints and adverse event cases including processing the patient data, adverse events reporting, Adverse event coding using Medraa, assessing the seriousness, Product coding using WHODD dictionary, Medical history coding, Narrative writing, causality and labeling assessment of the events according to the company core data sheet (CCDs) and country specific RSI documents.
• Diabetes and weight loss product case handling (company specific).

1. Bayer project
Work exposure :
Database: Argus

• Suspected Unexpected Serious Adverse Reaction (SUSAR) cases in clinical studies, strictly compliant to 7- Day and 15-Day timelines.
• Adverse event (AE) coding by MedDRA browser and drug coding by WHO-DD browser, working on ARGUS safety database, coding indications and patient history based on MedDRA.
• Processing of Solicited and Unsolicited reports (Partner, Legal and regulatory authority cases),Literature cases processing.
• Unblind the patient by Identifying SUSAR and performing code break using specific unblinding procedures and tools.
• Responsible for generating and forwarding appropriate queries and requests for clarification and/or follow up information to Safety Responsible personnel.
• Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance.
• Ensuring compliance (quality, procedures, regulations, timelines, and consistency) with local regulations and Company’s global Pharmacovigilance requirements.
• Task performed: Mentoring, peer QC, case assignment
• Pulmonary hypertension, blood thinner, antibiotics product case handling (company specific)