Drug Safety Associate
by Synowledge PV Services India Pvt Ltd in Mysore
Experience: 0 to 2 yrs. Posted on: 05 Feb
Walkin Interview from 7th February to 10th February from 10 AM
Applicants need to go to the venue mentioned or call on the number provided below
Job Description
Send me Jobs like this YEARS OF EXPERIENCE: 0-2 years of experience
EDUCATION: BDS only.
WORK LOCATION : Mysore
ESSENTIAL DUTIES AND RESPONSIBILITIES:
As Case Intake Member:
As Case Processor:
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:
OTHER RESPONSIBILITIES:
SPECIALIZED KNOWLEDGE AND SKILLS:
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:
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 & 10th Febraury, 2014
VENUE:
1. #120P-122P, Belagola Industrial Area,
K.R.S. Road,, Metagalli,
Near GRS Fantasy Park,
MYSORE,
Karnataka - 570017,India
2. #120/A, Elephant Rock Road,
Jayanagar 3rd Block
BANGALORE,
Karnataka,India
CONTACT PERSON :
1. Affan at Bangalore
2. Sania at Mysore
EDUCATION: BDS only.
WORK LOCATION : Mysore
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.
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 & 10th Febraury, 2014
VENUE:
1. #120P-122P, Belagola Industrial Area,
K.R.S. Road,, Metagalli,
Near GRS Fantasy Park,
MYSORE,
Karnataka - 570017,India
2. #120/A, Elephant Rock Road,
Jayanagar 3rd Block
BANGALORE,
Karnataka,India
CONTACT PERSON :
1. Affan at Bangalore
2. Sania at Mysore
Salary: Not Disclosed by Recruiter
Industry: Other
Functional Area: Other
Role Category: Other
Role: Other
Keyskills: Drug Safety Pharmacovigilence
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