Walk In for "DRUG SAFETY ASSOCIATE" on 11th & 12th October @ Bioclinica Mysore office.
Amazing opportunity for PHARMACY, DENTAL, AYURVEDA, HOMEOPATHY & NURSING freshers!
Bioclinica is presently hiring Pharmacy Graduates / Postgraduates ; MSc / BSc Nursing Freshers interested in building a career in Pharmacovigilance / Drug Safety.
Bioclinica India Pvt Ltd
Silver Spirit Tech Park
317 (P), (PII) 318,
Hebbal Industrial Area, Mysore-16
Position Title : Drug Safety Associate - MICC
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
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 + Night shift allowance
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.
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