Raghuram Akinapelli Email & Phone Number

India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Hyderabad, Telangana, India

➢ Leading the team handling Company Core Data Sheets (CCDS), local labeling deviations, US and EU label updates.➢ Providing expertise and support to the team on labeling strategies and processes.➢ Maintain regulatory compliant, competitive, and up-to-date Core Data Sheet (CDS) and Health Authorities queries related to label for the assigned products.

Hyderabad Area, India

Mysuru Area, India

Maximum Daily Dose (MDD) Documents:• Calculation of the MDD and preparation of MDD documents according to the content of labelling section, provided by client for fluid system and nutritional products.Aggregate reports:• Writing and reviewing the aggregate reports which include PADERs.Literature search:• Performing the weekly literature search and review to identify safety related articles using Embase database.

Pune Area, India

Roles• Prepare various kinds of aggregate reports such as Periodic Benefit-Risk Evaluation Report (PBRER), US Periodic Reports(PADERS) and Canadian annual reports (CARs).• Manage the productions of aggregate reports for assigned products including collecting, organizing, analyzing, presenting the data and drafting safety medical evaluations• Perform quality reviews for the reports prepared by the peer aggregate report writers.Responsibilities• Ensure preparation of timely, quality aggregate reports for assigned products.• Data quality review/correction.• Quality review of team member’s Aggregate Reports.• Preparation of Risk Management Plans (RMPs).• Attend a kick-off meeting and regular teleconferences with client and also team meetings, departmental meetings, required trainings, and related activities.Additional responsibilities• Writing and reviewing Labeling Justification Documents (LJD) for submissions to regulatory agencies for supporting changes to CCDS 4.8 and 4.9 sections.• Performs signal detection, monitoring and evaluation based on single cases and aggregate data.• Conduct and analyze, medical and scientific literature searches using critical judgment and professional / scientific expertise to support projects or queries.

» Experience in writing, reviewing of periodic safety documents [Periodic Safety Update Reports (PSURs), Summary Bridge Reports (SBR), Addendum Reports (AR)].» Writing case narratives for ICSR’s & PSURs.» Medical Information support: Responsible for providing mdical information and scientific support for consumer healthcare products to Physicians and Consumers.Case Processing:  Triage of Incoming Reports for Completeness, Legibility and Validity.  Data entry of case reports into Oracle AERS safety database.  Adverse event and drug coding by using MedDRA and WHODD.  Assessment of case reports for seriousness, causality and expectedness.  Quality review of all SAEs for data completeness.  Literature reviews.» Create and maintain project specific working files, case report files and project central files.» Preparing and updating SOP's according to client’s requirements.» Participating in Signal detection.» Involved in Oracle AERS Validation (OQ & PQ) and authored validation (OQ& PQ) documents.

Doctor Of Philosophy - Phd, Pharmacology

Ms In Ra, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs, 3.8

M.Pharmacy, (Pharmacology)

B.Pharmacy, (Pharmacology, Medicinal Chemistry, Ceutics, Cognosy)