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Drug safety Associate Jobs in Mysore - BIOCLINICA

Drug safety Associate
BIOCLINICA
0 to 3+ Years
BIOCLINICA
Last Date 02 Jun 2018

BIOCLINICA - Job Details

Date of posting: 03 Apr 18

  • Job Title :  Drug Safety Associate / Senior Drug Safety Associates
  • Location: Mysore
  • Years of Experience:  0 to 5 years
  • Qualification : B Pharmacy, M Pharmacy, Pharm D, BDS, MDS, BSc Nursing, MSc Nursing, BAMS, BHMS

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.
  •  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.

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.

Hiring Process : Face to Face Interview

Job Role : Others

About BIOCLINICA

BIOCLINICA ()  is a global specialty clinical trials services provider delivering expertise and technologies to enhance clinical research, data and analytics . Bioclinica delivers focused service supporting multifaceted technologies such as Medical Imaging, Cardiac safety services, Molecular marker laboratory, Drug Safety and Regulatory solutions, Network of research sites, patient recruitment-retention services, and a post-approval research division.

Bioclinica serves more than 400 pharmaceutical, biotechnology, and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia .  Bioclinica’s primary locations include:

Newtown, Pennsylvania – Global Headquarters
Audubon, Pennsylvania – eClinical Solutions Division
Princeton, New Jersey – Medical Imaging and Cardiac Safety Division
Newark, California – Medical Imaging
Portland, Oregon – Medical Imaging
Lyon, France – Regional Office
Munich, Germany – Regional Office
London, England – Regional Office
Shanghai, China – Regional Office
Tokyo, Japan – Regional Office
Mysore, India
Bangalore, India 

This posting is done directly & exclusively on Freshersworld.com. We do not entertain any unsolicited calls or enquiries from any consultants, other portals or TPOs. Notice: This recruitment is FREE. if the recruiter charges any fees, please write us info@freshersworld.com

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BIOCLINICA recruiting Drug safety Associate Experienced(0 to 3+ Years) candidates in Mysore. The BIOCLINICA vacancies for Drug safety Associate is filled through Face to Face Interview etc.
BIOCLINICA jobs for Experienced(0 to 3+ Years) candidates are very common in nature as the company recruits a lot of Experienced(0 to 3+ Years) candidates every year based on the skills . The candidates with M.Pharm, BDS, MDS, BAMS, BHMS, B.Pharm are selected to full fill the vacancies in Others job field. The Experienced(0 to 3+ Years) candidates applying for Drug safety Associate should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to BIOCLINICA recruitment, Experienced(0 to 3+ Years) candidates are mostly chosen for the department Others. To learn more about the current jobs and other details, it is better to go through official site of BIOCLINICA and Freshersworld. The Freshersworld is a leading employment portal that researches the official site of BIOCLINICA and provides details about the current vacancies, the application process, selection process, test details, important dates and other information.