Medical Safety

RESUME

NAME: DR.Manjunatha B.V.

QUALIFICATION: B.D.S (Bachelor of Dental Sciences)

ADDRESS: No. 87/7, 2nd floor, 3rd cross, 1st Main, New Narasappa Building,

Ganganagar, Bangalore-560032 [INDIA]

CONTACT: 098********, 093********.

E mail id: ***********@**********.***, ***********@*******.***

Year of Passing: April 2000

WORK EXPERIENCE

1. Quintiles Technologies Private Limited

[Aug 2008 to till now]

Job Description: Senior Aggregate Report Scientist (Quintiles

Pharmacovigilance Center)

Working for one of the Top 5 U.S pharmaceutical company in the world.

I am familiar with safety regulatory guidelines/references, how to access

them, and when to refer to them; PSUR (periodic safety update report)

experience (assemble and write). I provide scientific and technical

(including medical writing) support to the Global Pharmacovigilance

Product Safety physicians for all safety reports [individual cases and

aggregate reports, including responses to ad hoc queries regarding safety

issues; analysis and interpretation of safety issues arising from clinical

trials or post-marketing surveillance, preparation of aggregate reports

(e.g., periodic safety updates (PSURs), investigational new drug (INDs),

periodic adverse drug experience reports (PADERS), summary bridging

reports (SBRs), ad hoc reports, and safety sections of package inserts]. I

have an understanding of clinical data management in relating to assessing

clinical trial data. Also have knowledge of computer applications and

project planning skills.

I had undergone on-shore process related training in UK for 2 months in

aggregate reporting.

2. Accenture Services Private Limited (India Clinical Research Center)

[December 26, 2006 to July 31, 2008]

Job Description

Working in Medical Writing team as Document Quality Review Specialist.

Familiar with U.S FDA (ICH,GCP,SOPs) norms and working for one of the top 5

pharmaceutical companies in the world.

Thorough knowledge about both internal and external documents such as

protocols, clinical study reports, investigator’s brochures, manuscripts,

posters, abstracts, etc.

Ensures that the data and methods in all assigned documents agree with source

documents such as statistics summary tables, protocols, and statistical analysis

plans.

Checking text against summary tabulations and summary tabulations against

listings; checking data in graphics against tables; and confirming incorporation of

all protocol amendments and errata.

Verify the accuracy of submission summary documents against source

documents.

Assist Team Lead in coordinating activities like work load distribution, validating

ToOs from junior level reviewers, tracking documents of self and of the team,

responding to client mails and queries.

Edits all types of regulatory and publication documents.

Alert supervisors and document authors immediately if significant problems are

found during a data checking review.

Meet the productivity of 90%.

Meet the quality level across all documents at 90%.

3. Omega Healthcare Services Management Private Limited [April 2006 to December

2006]

Worked as Medical Coder for U.S Insurance Company on behalf of Hospitals

in Radiology Department.

Expertise in ICH(International classification of diseases) and CPT( Common

Procedural Terminology).

4. HealthOffice India Private Limited [June 2005 to April 2006]

Worked as medical transcriptionist for U.S Hospitals.

Familiar with medical terminologies.

5. Trinetra Dental Specialisties [Banashankari, Bangalore]

Worked as junior doctor for almost 5 years.

Took active participation in organizing dental camps and treating patients.

STRENGTHS

Excellent communication skills.

Basic knowledge of M.S word, excel, etc.

Good team bonding involvement.

Used to coordinate people and manage the team when necessary.

Pitch in an emergency situation to handle work effectively.

DATE: 04 September 2009

PLACE: Bangalore

Contact this candidate