Chaitra Chenna

• On an usual day I author the assigned periodic aggregate safety reports, such as PBRER/PSUR, DSUR, ACO etc. I also evaluate the signals presented in the aggregate reports. In collaboration with safety colleagues in cross functional teams, I thoroughly analyze and critically interpret data to determine the best approach.

Highlight:The drafted DSUR for a developmental product, was showcased as one of the important and best project in the year end global town hall.

• Often I also divulge myself to assess document requirements, gauge document complexity and identify information gaps or issues. In collaboration with the project coordinator, I have contributed to strategies to resolve any unidentified issues, produce high quality, accurate, and fit-for-purpose documents with clear conclusions while responding to internal or regulatory authority request for safety reasons.

• I review worldwide medical/scientific literature information for inclusion in aggregate safety reports in collaboration with safety colleagues as per the standard operating procedures (SOPs).

• I am inclined towards fostering innovation and improvement related to medical writing processes and documents.

• Provided suggestion pertaining to initiative and creativity in solving routine problems that affect multiple documents; ensures consistency between related documents.

• I am involved in drafting of regulatory response documents such as HA request assessment reports and other medical writing deliverables as needed.

Alongside routine responsibilities of authoring complex aggregate reports, in this role I was also involved in training the team of aggregate reports analysts of Pfizer vendor company Indegene which allowed timely and smooth outsourcing of the business to Indegene and helped the in house team to work effectively in COVID 19 reports.

The smooth and timely handover of project was well recognized by the global team.

Worked with global team of safety risk leads while authoring , peer reviewing of moderately complex aggregate reports e.g; PADER, PSUR, PBRERs, PSURs VOL 9A, Canadian Annual Reports, ACOs, HAQs, Adhoc regulatory responses, Addendum reports, China regional PSURs and DSUR.

• My primary expertise is handling of Triaging, data entry and verification of both spontaneous and solicited cases to ensure prioritization and to comply with the regulatory requirement. I have also handled adverse event reports categorized on basis of expeditedness in adherence to defined reference guidance and regulatory reporting timeframes.

• Perform data entry of adverse events from spontaneously reported non serious and serious reports; including reports from non-interventional source and perform narrative writing. Enter the reported information in the Novo Nordisk safety database – Argus.

• I was involved in performing monthly QC reviews for my team, conduct QC discussion meetings and file the MOM for quality auditing purpose.

• Ensure accurate and consistent coding of all events for serious and non-serious cases entered in the Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities), evaluate causality and listedness in the serious and non-serious cases.

• I was also the Project manager for a Local Project “Simplification of Allocation” and worked in SOP review team as a part of project simplification process.

• I have been trained in serious device cases, Novo rapid Pump cart cases and country specific cases from United States.

• I am a part of the steering committee of the Process automation project (RPA).