Aditya Gawas Email & Phone Number

Pune, Maharashtra, India

Pune, Maharashtra, India

Pune, Maharashtra, India

PV Safety mailbox management for tracking, managing, and assigning adverse events reports to processing users.Performing Intake and Data Entry of ICSRs into client safety database- Argus 8 and Aris Global LSIT v10; Triaging event coding using MedDRA, drug coding using the company and WHO drug dictionary, entering medical history, lab tests data, and generate narrative.Identify information to be queried and follows-up with the reporter until the information is obtained and queries are satisfactorily resolved.Using HP Resource Management (HPRM) for archiving and storing safety communications.Performing PQC line-listing for identifying, requesting, and updating PQC numbers in the database.Assists in the generation and distribution of regulatory reports as per applicable regulatory requirements.Participate in client Audit and inspection readiness.

Pune, Maharashtra, India

Performed Intake and assessment activity which includes;1. Identifying safety reportable information from the safety mailbox. assessing the case validity and performing data entry of these cases in the safety database Argus v7 and v8.2. Filing and maintaining paper signatures as per 21 CFR Part 11 guidelines.3. Generate adverse event queries, liaise with the medical reviewers and clients to agree upon the queries, and send a request for additional information to the sites/reporter.4. Engage with the DSO's, LP's and Clinical sites to ensure appropriate information is obtained timely.Played key role as an Intake and assessment SME in the transition of the safety database from Argus v7 to v8.Provided training and mentored new hires and peers on Intake and assessment workflow. Provided presentations on new workflow updates and activities.Organized on-floor employee engagement activities and outdoor team-building activities.Participated in client Audit and inspection readiness.

Pune, Maharashtra, India

Taught bachelor, XII, and X'th standard students for Biology, Microbiology, Immunology, and Medical Microbiology subjects and prepared them for academic exams.Helped in academic projects, prepared study material,s and conducted exams.

Pune, Maharashtra, India

- Carry out scientific research in the field of microbiology.- Collect and analyze data related to research.- Develop methodology and execute the experiments.- Prepare and present articles, reports, and presentations at conferences.

Master Of Science - Ms, Microbiology, A

Cumulative Grade Point Average (CGPA): 4.2/6 Percentage: 63.35%

Bachelor Of Science - Bs, Microbiology, A

Percentage: 64.15%