Drug Safety Associate...Synowledge PV Services India Pvt Ltd in Mysore...h1

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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 : 3rd & 4th July , 2014

 

VENUE:

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

 

CONTACT PERSON :

Affan @ Bangalore