Bioclinica Released Job Openings On 02/11/2021.Bioclinica’s global team of life science experts serve more than 500 pharmaceutical, biotechnology, and device organizations – including the top 20 biopharmaceutical companies and leading CROs – through locations in North America, Europe, and Asia.
Vacancy Details:
Bioclinica Recruiting Freshers For Junior Drug safety associate Position.Complete Details for the Junior Drug safety associate as follows.
Important Details :
- Location :Mysore
- Department : Pharmacovigilance
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 02/11/2021
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
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
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 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.
Hours:
- Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed.
- Willing to work in shifts as and when needed
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