Drug Safety Associate Jobs in Mysore - BIOCLINICA

• 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.