Charu Sharma

• Interaction with internal or external contacts to resolve issues related to the processing of ICSRs.

• Responsible for providing guidance and direction to a team of Drug Safety Associates. Mentored Drug Safety Associate to ensure confident coding of ICSRs.

• Experienced in management of Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies and solicited programs) 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.

- Registration/Initiation of ICSRs into the safety database.

- Conducting duplicate searches prior to registration and identifying potential duplicates.

- Data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labelling documents (such as SPC, CDS, IB etc.), writing case summaries and assessing causalities.

• Experienced in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”.

• Maintaining a good working knowledge of the AE safety profile of assigned drugs/class of drugs. Reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations including:

- ICH guidelines on safety and efficacy

- FDA guidelines

- CIOMS

- New EU PV legislation

- GVP

- EU-GDPR

• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.

• Acted as a Subject Matter Expert (SME) for the team- Handling queries required for medical assessment of the cases.

• Acted as a "Parexel trainer"- part of Parexel annual refresher training program.

· OPD handling.

· Oral diagnosis and X-rays interpretation.

· Extractions

· RPD and CD fabrication

· Restoration

· Anterior RCT

· Oral Prophylaxis