Drug safety Associate Jobs in Mysore - BIOCLINICA

Drug safety Associate
0 to 3+ Years
Drug safety Associate Jobs in Mysore - 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.
  • 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.
  • 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.


  • 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.

Job Summary

Job Type : Full Time
Job Role : Others
Job Category : Others
Hiring Process : Face to Face Interview
Who can apply : Freshers and Experienced (0 to 3+ Years )


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 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

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BIOCLINICA recruiting Drug safety Associate Experienced(0 to 3+ Years) candidates candidates nearby Mysore.BIOCLINICA vacancies for Drug safety Associate is recruited through Written-test, Face to Face Interview etc.
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