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Curriculum Vitae
VENKATESWARLU.RAVULA E- mail:ravula83@gmail.com
Mobile: +91-9945620835
Dear Sir/Madam,
World Courier, an AmerisourceBergen company a full-fledged clinical trial supplies
management facility (Storage and Distribution Facility) at Bangalore, India; storage and
distribution of Investigational products. Managed over 150 clinical trial protocols ( IMP
Supply chain/CTMS projects) of leading Global clinical services companies like Catalent
Pharma Solutions, Aptuit, Almac clinical services and big pharma majors like
Sanofi.Easai,Biogen Idec ,Daichii Sankyo.
Just to brief about myself, I completed Master of Science. I’m currently working at World
Courier, an AmerisourceBergen company as a Sr. Pharmacist Assistant (Team Leader) in
Clinical Supply solution for past 6.0 Years now.
SPECIALITIES:-
CTMS
Depot set up & Operations
IVRS/IWRS
IP Products/Clinical Trials
Packaging & Labeling
Distribution and Logistics
Cold chain management
Ancillary/Comparator Sourcing
Reconciliation/Accountability of return Medication
Destruction Activity: Study Close-out/Expired Medication.
Archival Study Documents
Work Experience:-
Working as a Sr. Pharmacist Operating Assistant (Team Leader) in World
Courier, Clinical Supply Solution, Bangalore from Feb 2014 to till date.
Role:-
- Supervised and managed team of three logistic operators and one pharmacist operating
assistant during the course of work.
- Plan and design of Protocol management as per SOPs.
- Maintain and assure compliance with applicable ICH, GMP and FDA Good.
Clinical Practices, local regulatory affairs, legal Requirements, and World Courier.
Standard Operating Procedures (or any other as required).
- Be familiar with the Protocol or any other related material of Clinical Products.
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- Comply with World Courier Standard Operation Procedures, which contain all the specific
instructions to take each step, as from the moment of reception until the shipment of the
product in question.
- Verify and keep in order, all the documentation received, shipment arrival conditions,
storage and all extra documentation related to each Product.
- Ensure that all the activities performed such as, reception, storage, labeling, shipment,
etc. are in accordance with the SOPs, previously established.
- Extensive re-labeling (expiry update labeling, additional labeling, just in time labeling)
experience for large study cutting across different clients.
- Ensure that the activities related to drugs returned, devolution and /or destruction are
perfectly performed according to the procedures established in each case, and
Documentation filed to.
- Identify and solve possible problems arising from personnel management that may be
against working schedules.
- Conducting Interactive web/voice response systems (IVRS/IWRS) transactions and IMP
inventory management (shipment receipt/dispatch/quarantine/release) for most of the
leading IVRS providers of client.
-Verification of documents as per Regulatory norms i.e. DCGI Approval Letter, Import
license, Certificate of analysis, Material safety data sheet, and all other related documents.
-Perfect selection of Shippers, Analyzing temperature and Configuration of Temperature
monitors.
-Maintaining track of all medications Expiry and Updation of their expiry after the
confirmation of Client/Sponsor, based on safety data and stability data.
-Reconciliation of the return medication received from clinical trial sites, perform statistical
analysis and destruction.
-Archival of trial related data for certain period of time as per GCP guidelines and Clients
decision.
- Assigning of values & Unit price calculations for the IND for Insurance and Customs
purpose.
- Preparation of monthly billing spreadsheets/Advise of charges for the movements done for
the clinical trial protocol to be forwarded to accounts team for billing purpose to clients.
Worked as- Pharmacist operating Assistant-CTSCS-WORLD COURIER (India)
Pvt. Ltd.-Clinical Trials Supply Chain Services from 02-MAY-2012 to 13-FEB-
2014.
Role:-
-Comply with World Courier Standard Operating Procedures (SOPs), which contain specific
instructions to take the steps concerned with reception, storage and shipment of materials.
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-The Pharmacist Operating Assistant must have the training and capability required to
control materials characteristics (described in their labels): ID number, expiration date,
patient’s kit, and temperature and storage conditions as well as any additional information
that could be useful.
-Perform the Inbound, Outbound or Return processes on CTM-Star Operative System.
- Large volume of depot to site,export,import shipments of
Pharmaceuticals/IMP/Vaccines/Hazardous/Dangerous/API/ Clinical supplies in Temp
Controlled,2-8˚C,Frozen,Dry-Ice,Liquid Nitrogen,Hazardous Materials,with 100% accuracy.
-Handled reception & inventorisation of bulk clinical supplies.
-IVRS/IWRS transactions and IMP inventory management for IVRS providers like Perceptive
Informatics,Clarix Informatics ,S-clinica ,CSDS-Impala, Clara,Braket & export/Import of IMP
and custom clearance procedures.
- Performing all the clinical supplies /protocol related transactions in company’s propriety
software application (CTM STAR).
- Providing updates to clients about the status /activities being carried out at depot for their
protocol through e-mail interactions/exchanges on daily basis.
- Have deep knowledge and carry out relabeling, stock, balance and relocations processes
developed at the Depot.
-Be in close contact with WC Operations on the shipments to be delivered to sites
coordination (if applicable).
Worked as - Logistic Operator CTSCS -WORLD COURIER (India) Pvt. Ltd.-
Clinical Trials Supply Chain Services 12-OCT-2009 to 01-MAY-2012
Role:-
-Worked from grassroots level in the field of Logistics
-Involved in consignment pick-up and delivery. Accompanied the consignments to various
cities throughout the country.
-Involved in customs clearance process, attaining no objection certificates (NOC) from
various government tax authorities especially in West Bengal and Orissa.
-Certified cold chain management professional. In and out knowledge of Packaging of
various categories, including but not limited to corrugated shippers, validated shippers etc.
-Involved in the reception of clinical trial shipments along with complete involvement in the
inbound process of a shipment.
-Worked in line along with the operations team along with management ofConsignments at
the depot.
-Thorough knowledge on Microsoft Outlook Express, and MS office.
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-Excellent knowledge in various process like, outbound, inventory management, drugs as
well as other types of shipments accountability process.
-Worked on Stock Control, balance sheet process as well as unit price calculations of all
types of consignments.
-Certified professional on World Courier’s exclusive software CTM-STAR which is US FDA
complaint for the Clinical research related products.
-Certified, trained as well as day to day involvement in handling, configuring and
conditioning of data (temperature) loggers of various types.
-Excellent knowledge on interacting with clients through telephonic as well as mailing
process.
Courses:-
World Courier - An AmerisourceBergen Company (Clinical Supply Chain Solution)
GMP
GCP
Cold Chain Management
Dangerous Goods
Education:-
-Master of Science in Marine Biology from Sri Venkateswara University, Tirupati
-Completed Bachelor of Science in Zoology, Fisheries Science, and Chemistry from P.R.R &
V.S Govt Degree College affiliated to Sri Venkateswara University, Tirupati.
-Completed Bachelor of Education in Biology from Amitha College of Education affiliated to
Bangalore University, Bangalore.
Personal Details:-
Date of birth : 11-05-1983.
Gender : Male.
Marital Status : Married.
Nationality : Indian Hindu.
Languages : English, Telugu and Kannada
Interests : Listening music, reading books and cricket.
Declaration:-
I hereby declare that all the above mentioned information is true to the best of my
Knowledge.
Yours truly,
Date:
Place: