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Offer: Drug Safety Freshers:Synowledge PV Services India Pvt Ltd 

Job description:

Drug Safety Freshers

Mangalore, Karnataka

Synowledge PV Services India Pvt Ltd 



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Job Description

suitable education B PHARMACY , M PHARMACY , PHARM D, BSC / MSC NURSING, BDS/ MDS, BHMS, BAMS

ESSENTIAL tasks 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 located 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 significant 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 reportcapability.
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 expertise:
Basic competence with medical and therapeutic terminology.
capability to work independently but guided by documented procedures, with appropriate support.
Able to work effectively as part of a team.
knowledge of patient safety regulatory obligations.
Should be familiar with regulatory &pharmacovigilanceguidelines.
Should be familiar with pharmacovigilance terminology.
Excellent attention to detail.
capability to deliver within established timelines.
Fluency in English and excellent comprehension.
Computer literate.
significant product and industry knowledge.
practice with significant software applications.
COMMUNICATION expertise:
Requires a proactive approach and excellent written/oral communication and interpersonal expertise.
Strong interpersonal expertise required to interact with clients, management, and peers effectively.
Effective cross department communication.
capability to document and communicate problem/resolution and information/action plans.
DESIRED TECHNICAL expertise:
Person should be familiar with MS Office Tools.
Safety database knowledge.

Company Description

Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related Information technology services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
  

Additional Information

Last updated:
. 18/03/2018
Employment Type:
. Full time
Employment type:
. Permanent
Vacancies:
. 100
Minimum practice:
. Less than one year
suitable education
. Compulsory Education
Job Category:
. Jobs in Healthcare / Medical / Pharmacy

Skills:

Job Category:  [ View All Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Mangalore, Karnataka
Company Type Employer
Post Date: 03/18/2018 / Viewed 5 times
Contact Information
Company: Synowledge PV Services India Pvt Ltd 


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