Drug Safety Freshers Walk In @ Mumbai on 23rd & 24th Feb - Bioclinica

BIOCLINICA at MUMBAI on 23rd & 24th February 2018!! 

Inviting PHARMACY,  DENTAL   & NURSING freshers interested in CORPORATE careers in PHARMACOVIGILANCE / DRUG SAFETY.


Interview Dates, Days : 23rd & 24th February 2018 ( Friday & Saturday)


Interview Time : 9:30 AM to 3:00 PM


Interview Venue:


NEW BRIDGE BUSINESS VENTURE
BOOMERANG BUILDING
B1/04-05, GROUND FLOOR, B WING,
CHANDIVALI ROAD, ANDHERI EAST, MUMBAI - 400072


CONTACT NUMBER : 9620212601




JOB TITLE: Drug Safety Associate

LOCATION: Mysore

YEARS OF EXPERIENCE: FRESHERS & 1 TO 3 YEARS EXPERIENCE IN PV

EDUCATION: B PHARMACY , M PHARMACY , PHARM D, BSC / MSC NURSING, BDS/ MDS

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 with regulatory &pharmacovigilanceguidelines.
• Should be familiar with pharmacovigilance terminology.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.
• Relevant product and industry knowledge.
• Experience with relevant software applications.
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.