Walkin on 11&12th July for Freshers&experience for Pharmacovigilance
Synowledge PV Services India Pvt Ltd
0 - 4 yrs
Mysore
Walkin Interview
11th July - 12th July 9 AM
Job Description
- WALK IN DATE : 11th & 12th July 2016
WALK IN TIME : 9:00 AM - 6:00 PM
Desired candidate Profile :
Drug Safety Associate:
Freshers Graduates/ Post Graduates in Pharmacy , Dental, Pharm D , BSc Nursing, with Excellent communication skills can attend.
Freshers Graduates/ Post Graduates in Pharmacy , Dental, Pharm D , BSc Nursing, with Excellent communication skills can attend.
Drug Safety Associate:
Any Healthcare professional With 1+ years of Pharmacovigilance experience can attend.
Any Healthcare professional With 1+ years of Pharmacovigilance experience can attend.
VENUE : Synowledge (Now a BIOCLINICA company)
# 120 / A, Elephant Rock Road, Jayanagar 3rd Block,
Bangalore -560 011
LANDMARK : Near The President Hotel, Opposite R.R.Gold Palace
# 120 / A, Elephant Rock Road, Jayanagar 3rd Block,
Bangalore -560 011
LANDMARK : Near The President Hotel, Opposite R.R.Gold Palace
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.
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.
Company Profile:
Synowledge PV Services India Pvt Ltd
About Us
BIOCLINICA (www.bioclinica.com) is a global specialty clinical trials services provider delivering expertise and technologies to enhance clinical research, data and analytics . Bioclinica is divided into three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division.
Bioclinica serves more than 400 pharmaceutical, biotechnology, and device organizations - including all of the top 20 - through a network of offices in the U.S., Europe and Asia . Bioclinica's primary locations include:
Newtown, Pennsylvania - Global Headquarters
Audubon, Pennsylvania - eClinical Solutions Division
Princeton, New Jersey - Medical Imaging and Cardiac Safety Division
Newark, California - Medical Imaging
Portland, Oregon - Medical Imaging
Lyon, France - Regional Office
Munich, Germany - Regional Office
London, England - Regional Office
Shanghai, China - Regional Office
Tokyo, Japan - Regional Office
Mysore, India- Synowledge (Acquired by Bioclinica)
Bangalore, India (Acquired by Bioclinica)
BIOCLINICA (www.bioclinica.com) is a global specialty clinical trials services provider delivering expertise and technologies to enhance clinical research, data and analytics . Bioclinica is divided into three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division.
Bioclinica serves more than 400 pharmaceutical, biotechnology, and device organizations - including all of the top 20 - through a network of offices in the U.S., Europe and Asia . Bioclinica's primary locations include:
Newtown, Pennsylvania - Global Headquarters
Audubon, Pennsylvania - eClinical Solutions Division
Princeton, New Jersey - Medical Imaging and Cardiac Safety Division
Newark, California - Medical Imaging
Portland, Oregon - Medical Imaging
Lyon, France - Regional Office
Munich, Germany - Regional Office
London, England - Regional Office
Shanghai, China - Regional Office
Tokyo, Japan - Regional Office
Mysore, India- Synowledge (Acquired by Bioclinica)
Bangalore, India (Acquired by Bioclinica)
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