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BIOCLINICA - Walk-In for B.Pharm, M.Pharm, Pharm.D, Nursing, Dental Graduate Freshers on 22nd February 2020
Walk- In at Bioclinica
Day, Date: Saturday, 22nd Feb 2020
Time: 9 AM to 1 PM
Venue:
Bioclinica, ABBHI Campus, #120 P- 122P,
Belagola Industrial Area, K R S Road,
Metagalli, Mysore - 570 016
Job Title: Jr Drug Safety Associate
Location: Mysore
Years of Experience: 0 to 1 years
Education: B Pharmacy, M Pharmacy, Pharm D, BDS, MDS, BSc Nursing, MSc Nursing
Essential Duties and 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.
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 with regulatory &pharmacovigilanceguidelines.
• Should be familiar with pharmacovigilance terminology.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.
• Relevant product and industry knowledge.
• Experience with relevant software applications.
COMMUNICATION SKILLS:
Requires a proactive approach and excellent written/oral communication and interpersonal skills.
Strong interpersonal skills required to interact with clients, management, and peers effectively.
Effective cross‑department communication.
Ability to document and communicate problem/resolution and information/action plans.
Desired Technical skillS:
• Person should be familiar with MS Office Tools.
• Safety database knowledge.
OTHER SKILLS:
• The ability to contribute to a team environment with a high degree of professionalism and skill.
• Demonstrate flexibility within a dynamic, fast-paced, cross-functional team. • Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast-paced environment.
• Ability to perform under stringent timelines.