Interview Day, Date : Saturday, 12th August 2017
Interview Time : 9 AM IST
Venue
BIOCLINICA
#120/A, Elephant Rock Road,
Jayanagar, 3rd Block, Bangalore -560011
Landmark : Near The President Hotel / Opposite R R Gold Palace
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
Requisites
Excellent verbal and written communication skills – The candidates have to interact with Global entities via Telephone
Willingness to work in night shifts
Interest in pursuing a career in Pharmacovigilance / Drug Safety
Benefits
Competitive salary +Incentives
Cab Facility
Employee Benefits
Exposure to Global Clients / Customers / Users
Opportunity to start a lucrative career In Pharmacovigilance / Drug Safety
Opportunity to work with top Pharma companies
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.
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