Walkin on 7 May 2014 for Drug Safety Associate @ Synowledge PV, Mysore for B.Pharma, M.Pharma Fresher candidates - Candidate must focus here on skills required for Job "D"

Experience: 0 to 1 yrs.
Walkin Interview on 7th May from 10 AM
Education: B.Pharm, M.Pharm etc
Walkin Date: 7th May, 2014
Walkin Time: 10 AM
Walkin Location:
#120P-122P, Belagola Industrial Area,
 K.R.S. Road,, Metagalli,
 Near GRS Fantasy Park,
 MYSORE,
 Karnataka - 570017,India
Synowledge Bangalore
#120/A, Elephant rock road,
Jayanagar 3rd Block,
Bangalore -560 011

Job Description

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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 : 7th May, 2014


 
 
VENUE:  . 1. #120P-122P, Belagola Industrial Area,
 K.R.S. Road,, Metagalli,
 Near GRS Fantasy Park,
 MYSORE,
 Karnataka - 570017,India



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

CONTACT PERSON :  
Sania@ Mysore
Affan @ Bangalore