Dodda Mrudhula Rajalakshmi

Skilled drug safety expert prepared for this role. Extensive experience in pharmacovigilance, risk management, and compliance. Strong focus on team collaboration and achieving results. Reliable and adaptable with excellent analytical and communication skills.

• Participated in the Indian Dental Conference, 2015
• Participated in Poster Presentation in development of tooth bud, held at Indian dental conference, 2016
• Got Best poster on GVP Module 6 in IQVIA
• Got ovation award for the work in IQVIA
• Got appreciation card for the work in IQVIA

ISEP Certification in Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs and Medical Writing, XCELCAREER Institute, Hyderabad, Telangana, 2020

• Father's Name: Dodda Srinivas
• Mother's Name: Dodda Jhansi
• Date of Birth: 04/18/97
• Gender: Female
• Nationality: Indian
• Marital Status: Unmarried

• Enter information into PVG quality and tracking systems for receipt and tracking ICSR.
• Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans.
• Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability.
• Enters data into safety database.
• Codes events, medical history, concomitant medications and tests.
• Compiles complete narrative summaries.
• Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
• Assists in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
• Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
• Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process.
• 4 years experience in Argus database