Raghavender Muthyala
Rajapur
Summary
TO PROVE MYSELF DEDICATED WORTH FULL AND ENERGETIC IN A PROGRESSIVE ORGANIZATION THAT GIVES ME SCOPE TO APPLY MY CREATIVE THOUGHTS AND SKILLS AND BE A MEMBER OF A TEAM THAT DYNAMICALLY WORKS TOWARDS ORGANIZATIONAL AND PERSONAL WORTH.
Overview
6
6
years of professional experience
Work History
Senior Executive in Pharmacovigilance Department
Micro labs
Bangalore
08.2024 - Current
- Authoring of PADER/PSUR/PBRER/ACO.
- Preparation of signal identification reports.
- Drafting of Risk Management plan for generic products.
- Handling of XEVMPD submissions.
- Handling of pharma ready database of PADER compilation and sequence creation for eCTD submission-USFDA.
- Drafting of SDEA(safety data exchange agreements).
- Actively participate in opioid analgesic risk evaluation and mitigation strategy.
- Review of PSUSA and PRAC preliminary assessment reports and providing response to the authority.
- Evaluation of Eudravigilence-eRMR data.
- Identification of safety changes in labeling documents-Europe,UK,USA and Australia molecules.
- Preparation and review of PADER, PSUR and SRR calendars as per approval list and EURD list.
- Monitoring of Healthy authority websites for safety of medicinal products like EMA, USFDA,CANADA,MHRA and TGA
- Handling of regulatory queries.
- Generation of Line listings from LSMV database-Summary tabulations, frequency reports, Periodic reports, external compliance reports.
- Update of company product dictionary in LSMV data base.
- Handling of PSMF and it’s activities.
- Marketing authorization and withdrawal products in annex H
Global Drug Safety Associate (Executive)
Shilpa Medicare Limited
01.2023 - 07.2024
- Preparation and Review of Periodic Safety Update Reports (PSUR)/ Periodic Benefit Risk Evaluation Report (PBRER)
- Preparation and review of Periodic Adverse Drug Experience Reports (PADER)
- Preparation and review of signal identification reports
- Preparation of risk management plan
- Handling of Individual Case Safety Reports (ICSRs) – Receipt of ICSRs from various sources, handling safety database, Workflow management, review of ICSRs, HA submissions and Compliance etc.
- Conducting the ICSR quality review meetings.
- Daily Monitoring of pharmacovigilance@shilpamedicare.
Global Drug Safety Associate (Executive)
Aurobindo pharma Limited
Bachupally
09.2019 - 12.2022
- Drafting of Periodic Adverse Drug Experience Reports (PADERs) for assigned products including planning, writing and finalization.
- Submission of periodic cases to FDA during the PADER preparation and finalization.
- Review of safety concerns from regulatory authorities.
- Submission of Final PADER reports which includes compilation of cover letter, 356h form and safety report of PADER via eCTD (Electronic common technical document).
- Monitoring of Pharma Ready database for the updates on labeling documents (PI) of respective molecules.
- Drafting Periodic Benefit Risk Evaluation Reports (PBRERs), Canada Annual Summary reports (CASR) for assigned products, including generation of line listings, collection of sales data, review of literatures and over all preparation of report and finalization
- Triage:
- PV mailbox monitoring for case intake
- Perform initial evaluation of reported adverse events (serious and non-serious) from all sources Maintenance of triage tracker as per SOP
- Prioritization of business partner sharing cases Based on timelines Handing and monitoring of EVDMS case and MLM cases
- Downloading of Evdms and MLM cases from Eudravigilence website on daily basis.
- Monitoring of ICSR search on each working day on the Eudravigilence website.
- Screening of number of Evdms cases and MLM cases received from Eudravigilence on daily basis.
- Handing and monitoring of Canada cases from Canada vigilance adverse reaction online database:
- Ensure Canada cases download from Canada vigilance adverse reaction online database.
- Screening of Canada cases from Canada vigilance adverse reaction online database.
- Ensure book in the valid cases on regular basis to prioritization of cases based on regulatory timelines.
- Book in:
- Book in of case reports including spontaneous cases, literature reports, MHRA E2B reports and cases downloaded from EVDMS database and in safety database by checking validness of case.
- ICSR case processing:
- Data entry of individual case safety reports (ICSRs) into database (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases as applicable).
- Code all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (e.g., MedDRA, company product dictionary, WHO-DD).
- Write medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.
- Perform peer review of all book in cases and resolve the queries related to book in (IRD wrongly captured, wrong source document attachment,) and evaluate seriousness criteria as per IME list and CTCAE.
- Quality review:
- Review of data entered in safety database for completeness and accuracy.
- Performing quality check of case against the source document. Entering any data found relevant during the review, quality check of coding events, indications, medical history, coding of suspect and concomitant drugs, action taken, DE challenge, rechallenge.
Education
Doctor of pharmacy - undefined
Pullareddy institute of pharmacy
01.2019
Intermediate - MPC
Viswa Vikas junior college
01.2013
SSC - undefined
Shatavahana high school
01.2011
Skills
- Have good Knowledge about Pharmacovigilance
- Workable knowledge of Microsoft office, Argus safety database, ARIS g and LSMV
- Ability to work collaboratively and effectively in a team environment
- Good presentation skills
PERSONAL DETAILS
- Name: Raghavender muthyala
- Date of Birth: 15-Aug-1996
- Gender: Male
- Languages: English, Telugu, Hindi
- Marital status: Married
DECLARATION
I hereby declare that all stated in this form are true to the best of my knowledge and belief.
Place: Hyderabad
RAGHAVENDER MUTHYALA
Senior aggregate reports writer
Timeline
Senior Executive in Pharmacovigilance Department
Micro labs
08.2024 - Current
Global Drug Safety Associate (Executive)
Shilpa Medicare Limited
01.2023 - 07.2024
Global Drug Safety Associate (Executive)
Aurobindo pharma Limited
09.2019 - 12.2022
Doctor of pharmacy - undefined
Pullareddy institute of pharmacy
Intermediate - MPC
Viswa Vikas junior college
SSC - undefined
Shatavahana high school