CURRICULUM VITAE

VANKAYALA GOPI KRISHNA,

S/o V. Rama Rao,
H No: 8-325,
Piduguralla -522413
Guntur District, A. P.
: [email protected]
 : +91-7075692372
Career Objective:
I am a registered pharmacist and post graduate in Pharmacy with 2+ years of experience in pharmacovigilance
domain and currently looking for developing my career as a top developer in an organization with definite bias
on drug safety and clinical research and to take up new challenges in high growth expanding corporate and
prove my credibility and talent to grow to position of eminence and contribute substantially to the organization

Professional Experience:

Bioclinica India Pvt.Ltd

• Senior Drug safety Associate
(formerly Snowledge India Pvt. Ltd)
May 2018 to till date

Bioclinica India Pvt.Ltd

• Drug safety Associate
May 2016 - May 2018

KLR Pharmacy college,

• Assistant Professor Paloncha, Telangana state
Oct 2013 to Apr 2016

Academic Profile:

Post Graduation M. Pharmacy, 2011 to 2013

Specialization Pharmacology
Institute KLR Pharmacy College, Paloncha
University Kakatiya University, Warangal
Percentage 78.00%

Graduation B. Pharmacy, 2008 to 2011

Institute Arulmigu Kalasalingam Collegey of Pharmacy
University Tamil Nadu, Dr. M.G.R Medical University,
Percentage 73.00%

Experience in case processing:

➢ Proficient in triaging and prioritizing the safety information received via various sources.
➢ Processed Clinical trial (including SUSARs), Spontaneous and Solicited reports.
➢ Hands on experience of global drug safety data bases- ARISg.
➢ Expert in writing narratives for ICSRs.
 Responsibilities as Senior Drug safety Associate:

➢ Accountable for mentoring newly joined associates for initiating the receipt items in Inbound receipt Triage (IRT).
➢ Accountable as SPOC for Communication Module
➢ As a Quality Reviewer, evaluate AE case information to determine required action based on and following internal
policies and procedures
➢ Accountable for Triage of literature case reports.
➢ Monitoring and Processing deletion workflow (case deletion and request deletion) activity.
➢ Accountable for clinical trial reconciliation process, as well as reconciliation activities associated with Safety Data
Exchange & Pharmacovigilance Agreements.
➢ Accountable for processing SAE reconciliation's and line listing from licensee partners.
➢ Assuring compliance with the use of Client Safety database through reference of latest SOPs and relevant
manuals.
➢ Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive work flow
management.
➢ Representing Drug Safety in regulatory and internal inspections and audits as required.

Responsibilities as Drug safety Associate :

➢ Worked on tool ARISg (7.1, 7.2 and 7.4).

➢ Accountable for handling ICSRs disposition of valid items into ARIS from IRT for further processing in ARISg (case
initiations).
➢ Acknowledging receipt of ICSRs to sender within the timelines documented in the relevant SOP.
➢ Accountable for handling invalid items in IRT appropriately through reference to SOPs, relevant training and the
ARIS user manual.
➢ Sending MedDRA requests as needed and discussing with operation physician team regarding the
amendment/split and raising queries regarding the events.
➢ Narrative writing as per regulatory format.
➢ Accountable for sending queries for clarity associated with incoming information if required.
➢ Accountable for performing accurate data capture for individual case safety reports which can be spontaneous,
clinical, NIP and NIS cases.
➢ Accountable for performing the appropriate clinical assessments (including the assessment of seriousness,
labeling and company causality for each adverse event) adhering to SOPs/other controlled documents and
regulatory requirements.
➢ Responsible for identifying duplicate/invalid ICSRs in ARIS and handling as per relevant SOP.
➢ Responsible for generating and forwarding appropriate queries and requests for clarification and/or follow up
information

Achievements

• As data entry associate processed 1800+ ICSR’s during my tenure.

• As a triager handled 3000+ ICSR’s, 200+ literature cases, handling of Global and local IRT
communications, Business partner communications.
• As a quality reviewer handled 700+ ICSR’s.
• Received “power” recognition from Client for identifying maximum number of duplicate
cases during the tenure.

Computer Proficiency:

Microsoft Package : MS Word, Excel, Power point

Technical Software : DTP, Photoshop.
Operating System : Windows 8&7, WindowsVista, Windows 98, Windows 2000.
Knowledge and Skills

• Overview of Indian and Global Clinical research Industry.

• Basic knowledge on ICH - GCP guidelines.
• GVP modules and Schedule Y.
• Knowledge on MedDRA.
• Excellent understanding of physiology, pharmacology, Microbiology, clinical study objectives, and the
drug development process.
• Good communication and interpersonal skills.

Publications: National & International

1. Immune Enhancing Activity Of Methanolic Extract Of Flowers Of Ixora Javanica; An International
Journal of Advances in Pharmaceutical Sciences; Volume 5 Issue 6 November – December 2014;Pages
2555-2558. (Impact Factor – 3.858)
2. Immunomodulatory activity of methanolic extract of asarum europaeum roots in IJKLR vol-1, February
- 2014.
3. Identification of Besnier – Boeck- Schaumann (Sarcodiosis) in a Patient with pyrexia of unknown
origin, in IJKLR vol-1, August – 2014.

Symposium and Seminars Attended:

1. Worked as Assistant coordinator for NEC – 2015 at 67th IPC, Mysore.

2. A lifetime member in Indian Pharmaceutical Association (IPA) since 2014.
3. Attended APTICON held on Aug 2013 at Rajahmundry.
4. Poster Presentation on “Antihyperglycemic activity of Justicia Simplex on alloxan induced diabetic rats”
at 4th student congress IPA at Warangal.
5. Poster presentation on “Need of Pharmacy Practice – A focus on Patient care” at Vikas Institute of
Pharmaceutical sciences, PCI sponsored Seminar at Rajahmundry.
6. Attended as a delegate in national seminar on Recent Trends & Future Perspectives In Pharmaceutical
Sciences at Arulmigu kalasalingam college of pharmacy, Krishnan kovil, Tamil Nadu .
7. Participated in the ICMR- Sponsored national conference on “Drug Discovery From Medicinal Plants” held
at Arulmigu kalasalingam college of pharmacy, Krishnan kovil, Tamil Nadu.
8. Participated in elocution competition arranged under people education program by Divisional Office,
Khadi and Village Industries Commission, Madurai at Kalasalingam university, Krishnan kovil, Tamil Nadu.
Personal Details:

Name : Vankayala Gopi Krishna

Date of Birth : 14th Aug, 1989
Nationality : Indian
Gender : Male
Marital Status : unmarried
Languages known : Telugu, English, Hindi & Tamil.
Address for communication : S/o V. Rama Rao
H No: 8-325
Near old post office
Opp Andhra Bank Street
Piduguralla -522413
Guntur District, AP

DECLARATION

I hereby declare that the above furnished information is true to the best of my knowledge.

Date: Yours faithfully,

Place: (V. GOPI KRISHNA)