Walk in Interview for Drug Safety Associate at Bioclinica | Fresher apply

Bioclinica is utilizing data and technology to enable more efficient trial conduct. We are looking at ways to reduce the size of the trials, provide greater clarity into the effect of the drug, and to reduce the amount of complexity in the trial. We do this by improving trial design and utilizing advanced analytics to identify patients who would be high responders for a particular clinical trial.

Post : Drug Safety Associate

Job Description
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.

Additional Information
Work Location : Mysore
Shift Timings : 5:30 PM to 2:30 AM (with Cab facility)
Experience : 0 to 5+ Years ( ANY)
Education : Bachelors / Pharmacy / Nursing

Walk In Interview
Date : 11th and 12th of October anytime between 9 AM to 2 PM IST
Venue : Bioclinica India Pvt Ltd Silver Spirit Tech Park 317 (P), (PII) 318, Hebbal Industrial Area, Mysore-16

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