V.S.P.Krishna Chaitanya Kidambi #**, Sri Hari Nilaya

1st floor, 2nd Main road

1st Block East Jayanagar

Byrasandra

Bangalore-560011

India

ac0cpc@r.postjobfree.com

Mobile: +91-805*******

Young, energetic and result oriented professional with 6 years of core experience in Pharmacovigilance; Deep understanding of technology with focus on delivering business solutions;

• Exceptional communication, analytical & inter personal skills and problem solving skills.

• Adroit at learning new concepts quickly, working well under pressure and communicating ideas clearly and effectively.

• Dedicated and highly ambitious to achieve personal as well as organizational goals.

Academics

Distinction in M.Sc Clinical research Management from ICRI (2009- 2011).

Distinction in Bachelors of Pharmacy from Hindu college of Pharmacy, Andhra Pradesh (2005-09)

Distinction in Intermediate from the Board of Intermediate, Andhra Pradesh (2002-04)

Professional Expertise

Organization: Quintiles Research Pvt LTD (04-Aug-2014 to till date) Role: Operations Specialist

Job description:

• Receive and document incoming faxes from investigative sites or other sources reporting AEs, serious adverse events (SAEs) and spontaneous events; collect, track required data and enter into safety database, if applicable.

• Follow up with sites to obtain missing data as required. Process data according to applicable regulations and guidelines, SOPs, and project requirements.

• Triage and classify incoming events; prioritze event case according to regulatory and project requirements.

• Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines.

• Create complete, accurate and succinct narratives adhering to established project template.

• Quality review of ICSRs and providing active feedaback for the improvement of project quality.

• Providing assistance to reconciliation with sites.

• Provide regular reports to overall project manager and department management on project metrics and document project issues to project team members and department management in a timely manner; with guidance, complete regulatory reports.

Organization: Synowledge PV services Pvt India ltd. Experience: 01-Mar-2014 to 31-Jul-2014

Role: Associate Team lead- Pharmacovigilance

Job description:

• Maintain current incoming cases in order to meet timelines (compliance monitoring)

• Follow up with clients regarding outstanding queries and reconciliation of discrepancies.

• Request for deletion of cases, if required.

• Ensure that team follows workflow procedures, SOPs, and case processing guidelines.

• Train, mentor, oversee and guide the activities of Drug Safety and Senior Drug Safety Associates.

• Completing appraisal process for the team.

• Participate in hiring process for the team.

• Maintain high level of proficiency at all workflow tasks.

• Perform any other drug safety related activities as assigned.

• Develop reports in Business objects.

• Work with cross-functional divisions including Customer support and Professional service

Organization: Synowledge PV services Pvt India ltd. Roles: Senior Drug Safety Associate (Jan-2013 to Feb-2014) Drug safety Associate (Jun-2011 to Dec-2012)

Databases worked on

1. Arisg 5.1

2. Arisg 6.0

3. Arisg 7.0

4. Argus 5.1.1

5. Argus 7.0.1

Types of cases handled

• Spontaneous Serious cases

• Spontaneous non-serious cases

• Clinical trial cases

• Literature Cases

Key Deliverables

• Triage of cases

• Case Processing

• Quality check Reviewer

• MedDRA Coding

• Medical writing/Narrative Writing

Specialized knowledge and skills

• High level of commitment and sincerity.

• Sound knowledge on Pharmacovigilance guidelines- US FDA and EU

• Good knowledge GVP- Module 6, CIOMS, ICH-GCP guidelines.

• Basic competence with medical and therapeutic terminology.

• Ability to work independently but guided by documented procedures, with appropriate support.

• Trained and working along the guidelines of GVP, EUDRALEX Vol.9A, Vol.10, 21 CFR of the FDA, etc

Personal profile

Name : V.S.P.Krishna Chaitanya kidambi

Date of Birth : 02-August-1986

Nationality : Indian

Gender : Male

Marital Status : Un-Married

Languages Known : English, Telugu

Reference : Available on request

I here by declare that all the statements mentioned above are true to the best of my knowledge and belief.

V.S.P.Krishna Chaitanya Kidambi

Place: Bangalore

Date: 17-May-2017

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