Walk-in- Pharmacovigilance ( Drug Safety )
Synowledge PV Services India Pvt Ltd
0 - 1 yrs Mysore
Synowledge PV Services India Pvt Ltd Careers
Walkin Interview
4th April 9 AM
Job Description Send me Jobs like this
Work Location: Mysore
Interview Location: Bangalore Office
Drug Safety Associate
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.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area: Other
Role Category:Other
Role:Other
Keyskills
Pharmacovigilance Drug Safety Meddra Ae Ms Office Tools Medical Coding Communication Skills Safety Analysis Strong Interpersonal Skills Problem Resolution
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy, BDS - Dentistry, MBBS - Medicine
PG:M.S/M.D - Any Specialization, M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
Please refer to the Job description above
Company Profile:
Synowledge PV Services India Pvt Ltd
Synowledge is a Global Management Consulting, Technology Services and Outsourcing Company focused in the Life Sciences & Healthcare Industry. With an annual growth rate of 300% and serving clients across 6 global offices (US, EU and Asia Pacific), Synowledge has gained market share to become the leading service provider in its space. Combining unparalleled experience and specialized capabilities within the Life Sciences industry, Synowledge has become a strategic partner with many Top 20 Pharma and Fortune 500 companies. Synowledge's technology solutions and innovative consulting services help life sciences companies reduce cost, accelerate growth and minimize time to market during the drug development lifecycle.
Address:#120/A, Elephant Rock Road,Jayanagar 3rd BlockBANGALORE,Karnataka,India 560011
Telephone:91-80-22448841
Synowledge PV Services India Pvt Ltd
0 - 1 yrs Mysore
Synowledge PV Services India Pvt Ltd Careers
Walkin Interview
4th April 9 AM
Job Description Send me Jobs like this
Work Location: Mysore
Interview Location: Bangalore Office
Drug Safety Associate
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.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area: Other
Role Category:Other
Role:Other
Keyskills
Pharmacovigilance Drug Safety Meddra Ae Ms Office Tools Medical Coding Communication Skills Safety Analysis Strong Interpersonal Skills Problem Resolution
Desired Candidate Profile
Education-
UG: B.Pharma - Pharmacy, BDS - Dentistry, MBBS - Medicine
PG:M.S/M.D - Any Specialization, M.Pharma - Pharmacy
Doctorate:Any Doctorate - Any Specialization, Doctorate Not Required
Please refer to the Job description above
Company Profile:
Synowledge PV Services India Pvt Ltd
Synowledge is a Global Management Consulting, Technology Services and Outsourcing Company focused in the Life Sciences & Healthcare Industry. With an annual growth rate of 300% and serving clients across 6 global offices (US, EU and Asia Pacific), Synowledge has gained market share to become the leading service provider in its space. Combining unparalleled experience and specialized capabilities within the Life Sciences industry, Synowledge has become a strategic partner with many Top 20 Pharma and Fortune 500 companies. Synowledge's technology solutions and innovative consulting services help life sciences companies reduce cost, accelerate growth and minimize time to market during the drug development lifecycle.
Address:#120/A, Elephant Rock Road,Jayanagar 3rd BlockBANGALORE,Karnataka,India 560011
Telephone:91-80-22448841
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