Drug Safety Associate Jobs in Mysore - BIOCLINICA

Drug Safety Associate
B.Pharm, MSc(Bio-Chemistry, Bio-Informatics, Biology, Bio-Physics, Bio-Tech, Chemistry, Microbiology)
Last Date 12 Aug 2017

BIOCLINICA - Job Details

Date of posting: 09 Aug 17

  • Position Title : Drug Safety Associate
  • Work Location : Mysore, Karnataka, India
  • Shift Timings : Night Shifts (US Shifts)
  • Education : B Pharmacy / Bachelor’s / Master’s in Science / Bio-Informatics / Biochemistry / Biomedical / Biotechnology / Clinical Microbiology / Medical Biotechnology / Biological Science / Biomedical Sciences / Biosciences /Life Sciences / Medical Biochemistry / Medical Microbiology / Molecular Biology / Life Sciences / Clinical Research / Biophysics / Medicinal Chemistry / Nuclear Sciences

Role & 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.

As Call Handler

  • Receive information or inquiry through phone call/email/fax/mail and create a record in Annexures.
  • Follow the documentation guidelines on AE/PC/MI calls.
  • Enter all the information pertaining to significant phone caIIs, emails, faxes, mails for internal tracking and reconciliation.
  • Responsible for resolving queries on phone calls related to AE/SAE, product complaints and medical information received by all source types (phone call/email/fax/mail).
  • Responsible for following good documentation practices while documenting information in Annexures.


  • 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.

Job Summary

Job Type : Full Time
Job Role : Others
Job Category : Others
Hiring Process : Face to Face Interview
Who can apply : Freshers


BIOCLINICA ()  is a global specialty clinical trials services provider delivering expertise and technologies to enhance clinical research, data and analytics . Bioclinica is divided into three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with safety and regulatory solutions. Under the Global Clinical Researchsegment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division.

Bioclinicaserves 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- Synowledge (Acquired by Bioclinica)

Bangalore, India (Acquired by Bioclinica)


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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