Bioclinica Recruitment August 2020.Bioclinica is specifically structured to create clarity in the clinical trial process—so you can make better decisions. Bioclinica is divided into three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory.
Important Vacancy details:
- Post Name: Drug Safety Professionals
- Education : M.sc,B Pharmacy, M Pharamcy, Pharm D, BDS
- Experienced:1 to 3 years
- Location: Mysore
- Salary :NA
- Openings :NA
Job Description: We have requirement for the post of Drug Safety Professionals in Bioclinica !
As Quality Check Reviewer
- Review data entered in safety database for completeness and accuracy.
- Provide quality feedback to team resources
- Track and maintain quality metrics
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.
- Following up with sites regarding outstanding queries.
- Follow up on reconciliation of discrepancies.
- Follow departmental AE workflow procedures.
- Closure and deletion of cases.
- Mentor and guide the activities of the Dug Safety Associate.
- High level of proficiency al all workflow tasks.
- Perform any other drug safety related activities as 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 &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.
- Relevant product and industry knowledge.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online