Walk in interview for freshers B.PHARM, M.PHARM, BDS, BAMS, BHMS, PHARM D, BPT, BSC NURSING on 16 june.14 @ Bangalore, Mysore - SYNOWLEDGE For the post of Narrative writer/D.S.A./Medical Coder - Freshers click to learn Roles & responsbilities For there benefit, if they unable to attend - "D2"

Drug Safety Associate

by Synowledge PV Services India Pvt Ltd in Mysore

Experience: 0 to 1 yrs. Posted on: 13 Jun

Job Description

YEARS OF EXPERIENCE : 0-1 year experience in Pharma/Clinical research.

EDUCATION : HEALTHCARE PROFESSIONAL DEGREE (BACHELOR/MASTERS) E.G., B.PHARM, M.PHARM, BDS, BAMS, BHMS, PHARM D, BPT, BSC NURSING

ESSENTIAL DUTIES AND RESPONSIBILITIES:

As Case Intake Member:

• Responsible for case intake, duplicate check , and registration
• Maintain log of source documents and other communications
• As Case Processor:
• Responsible for data entry of individual case safety reports into the safety database.
• Review and evaluate AE case information to determine required action based on and following internal policies and procedures
• Process all incoming cases in order to meet timelines
• Full data entry including medical coding and safety narrative

As Medical Coder :

Responsible for coding all medical history, events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)

As Narrative Writer

Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

As Literature Review Specialist

• Ensure effective and accurate collection, recording, review and reporting of literature searches conducted.
• Review of literature articles to identify case safety reports.
• Responsible for operational Pharmacovigilance activities for assigned developmental and/or marketed products.
• Assist in signal generation and safety analysis activities.
• Ensure quality of literature searches and reporting.
• Review of local/global literature reports to determine regional reportability.
• Create/maintain study summary documents.
• Assist with narrative writing for periodic/ad hoc submissions.
• Assist with ad hoc or routine safety monitoring activities.

OTHER RESPONSIBILITIES:

• Following up with sites regarding outstanding queries.
• Follow up on reconciliation of discrepancies.
• Follow departmental AE workflow procedures
• Closure and deletion of cases
• Perform any other drug safety related activities as assigned
• Perform literature review activities when trained and assigned.

SPECIALIZED KNOWLEDGE AND SKILLS:

• Basic competence with medical and therapeutic terminology.
• Ability to work independently but guided by documented procedures, with appropriate support.
• Able to work effectively as part of a team.
• Understanding of patient safety regulatory obligations.
• Should be familiar regulatory & pharmacovigilance guidelines.
• Should be familiar with pharmacovigilance terminology.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.

COMMUNICATION SKILLS:

Requires a proactive approach and excellent written/oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross- department communication. Ability to document and communicate problem/resolution and information/action plans.

DESIRED TECHNICAL SKILLS :

Person should be familiar with MS Office Tools.
Safety database knowledge.

OTHER SKILLS:

The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment. Ability to perform under stringent timelines.



DATE : 16th June , 2014



VENUE:
Synowledge Bangalore
#120/A, Elephant rock road,
Jayanagar 3rd Block,
Bangalore -560 011

#120P-122P, Belagola Industrial Area,
K.R.S. Road,, Metagalli,
Near GRS Fantasy Park,
MYSORE,
Karnataka - 570017,India


  CONTACT PERSON :



Affan @ Bangalore


Sania @ Mysore

Drug Safety AssociatePharmacovigilence

Desired Candidate Profile

Education:

UG - B.Pharma - Pharmacy, BDS - Dentistry
PG - M.Pharma
Doctorate - Doctorate Not Required

Please refer to the Job description above