Swatti Bhatowa

Pharmacovigilance experience:

• Management of individual safety case report (ICSRs) of different case types (spontaneous and non-clinical study courses) which includes:

- Triage of ICSRs to determine whether they qualify for expedited reporting or not and the timelines within which they need to be submitted to the regulatory authorities

- Conducting duplicate searches and identifying potential duplicates prior to book-in of ICSRs

- Data entry of ICSRs in the safety database (ARGUS)

· Trained in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”

• ·Good Working knowledge of data entry conventions and international regulations for vaccines and drugs including:

- ICH guidelines on safety and efficiency

- New EU PV legislation and GVP modules

- FDA guidelines

• Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with timelines for processing ICSRs.
• Organizing workload to ensure compliance with internal and regulatory timelines.
• Providing support in audits, inspections and inspection readiness activities, as required.
• Performing additional activities, as directed

Dentistry experience:

• Increased patient retention rates by building trust through transparent communication regarding treatment options, risks, benefits, costs involved during consultations
• Planned and administered local anesthesia and sedation.
• Root canal treatments in both adult and pediatric patients
• Bleach, clean and polish teeth to restore natural colour
• Fabrication of removable and fixed prosthesis including complete dentures, crowns, and bridges
• Extraction of teeth

• Responsibilities during internship

- Counsel the patients.

- Prepare & submit Syllabus- oriented Charts & Models for sessions

- Assist senior professors for various surgeries.
- Participate in various dental health screening and treatment programs
- Organize field visits in rural and urban areas during the internship and diagnosed various dental cases.