BIOCLINICA Hiring for Junior Drug Safety Associate
DEPARTMENT :- Pharmacovigilanc
As Case Intake Member
Essential Duties and Responsibilities:
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.
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
• Should be familiar with pharmacovigilance terminology. guidelines.
• Excellent attention to detail.
• Ability to deliver within established timelines.
• Fluency in English and excellent comprehension.
• Computer literate.
DESIRED TECHNICAL SKILLS
Person should be familiar with MS Office Tools.
Safety database knowledge.
APPLICATION PROCESS :-
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