Drug Safety Associate...Synoledge...WALK -IN's on 16th and 17th June'14....h2

Job Description

Send me Jobs like this

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 : 16th June , 2014

 

VENUE:

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

 

#120P-122P, Belagola Industrial Area,

K.R.S. Road,, Metagalli,

Near GRS Fantasy Park,

MYSORE,

Karnataka - 570017,India

  CONTACT PERSON :

Affan @ Bangalore

Sania @ Mysore

Salary:

Not Disclosed by Recruiter

Industry:

Other

Farea:

Other

Role Category:

Other

Role:

Other

Keyskills:

Drug Safety AssociatePharmacovigilence

Desired Candidate Profile

Education:

UG - B.Pharma - Pharmacy, BDS - Dentistry 
PG - M.Pharma 
Doctorate - 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.

Contact Details

Contact Company:

Synowledge PV Services India Pvt Ltd

Telephone:

6643700