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Drug Safety Associate Jobs in Mysore - BIOCLINICA

Drug Safety Associate
BIOCLINICA
B.Pharm, MSc(Bio-Chemistry, Bio-Informatics, Biology, Bio-Physics, Bio-Tech, Chemistry, Microbiology)
BIOCLINICA
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.

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.

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 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 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 fresher’s in Mysore. The BIOCLINICA vacancies for Drug Safety Associate is filled through Face to Face Interview etc.
BIOCLINICA jobs for fresher’s are very common in nature as the company recruits a lot of fresher’s every year based on the skills . The candidates with B.Pharm, MSc(Bio-Chemistry, Bio-Informatics, Biology, Bio-Physics, Bio-Tech, Chemistry, Microbiology) are selected to full fill the vacancies in Others job field. The fresher’s 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, fresher’s 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.