Pharmacovigilance Reviewer Job in Unikaihatsu Software Private Limited
Pharmacovigilance Reviewer
Unikaihatsu Software Private Limited
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
- Permanent
Job Summary
Position Pharmacovigilance Reviewer Reporting to Team Leader or Manager Qualifications / Work Experience Formal Education
Graduate, preferably in science
Bachelor s degree / Masters in Life sciences
MBBS/BHMS/ BAMS/ BDS/ Paramedical degrees
B. Pharm/ M. Pharm
Bachelors / Masters in Clinical research
University degree in pharmaceutical sciences or other relevant
medical or scientific disciplines preferred
Certifications
Certifications / Diploma in IT &/ CDM
Work Experience
Previous Pharmacovigilance / ICSR processing experience
Candidate having equivalent qualifications, training & experience may be considered.
Essential Competencies (Knowledge, Skills and Attributes) Expected Competency Domain
Good technical knowledge of medical terminology
Compliant with GCP/GCDMP
Computer and Internet skills and experience (familiarity and comfort with MS Office products)
Oral and written English communication skills
Self-motivated and enthusiastic
Accountability Domain
Understand and comply with Standard Operating Procedures
Anticipate problems, issues, and proactively work to minimize the impact
Maintenance of strict confidentiality in all CAC-India projects
Responsible for Data Quality
Accountable for customer satisfaction of all CAC-India stakeholders
Build constructive and effective relationships with study team, departmental associates and others (both inside and outside the company).
Key Responsibilities: Safety Data Processing
Review and Assess all source documents and compile data in an adverse event report mentioned in the ICSR
Oversees and performs and ensures case receipt and triage activities are completed for Individual Case Safety Reports (ICSRs) from all sources and ensure this is performed in a timely manner Data enter report into the client safety database
Concentrate on quality of work to get error free data
Code averse events in the client safety database
Responsible for and ensures the reconciliation of the safety database with ICSR source files
Release reports to client through client safety database
May be asked to perform ICSR case processing activities as a backup for safety information cases (including initial data entry of safety information, initial determination of seriousness, expectedness, listedness, and Reportability.)
Effective communication with study teams and departmental associates
Check labelling and correct the information
Submit the report as per the timelines
Participates in or assists in leading special projects and process development or improvement activities
Provide support for business owner of global safety database and related systems (i.e. testing and validation, identification of database enhancements, change control activities.)
Additional Information Industry type
Pharma/ Biotech/ Clinical research
Functional Area
Life science
Location Mumbai Working Hours As per company policy or depending on Project requirement Travel Not Required Job Code R145 E-mail recruitbpo@usindia.com Sub Line REQ 2019 Q4 R145 Ref: (usindia)
Graduate, preferably in science
Bachelor s degree / Masters in Life sciences
MBBS/BHMS/ BAMS/ BDS/ Paramedical degrees
B. Pharm/ M. Pharm
Bachelors / Masters in Clinical research
University degree in pharmaceutical sciences or other relevant
medical or scientific disciplines preferred
Certifications
Certifications / Diploma in IT &/ CDM
Work Experience
Previous Pharmacovigilance / ICSR processing experience
Candidate having equivalent qualifications, training & experience may be considered.
Essential Competencies (Knowledge, Skills and Attributes) Expected Competency Domain
Good technical knowledge of medical terminology
Compliant with GCP/GCDMP
Computer and Internet skills and experience (familiarity and comfort with MS Office products)
Oral and written English communication skills
Self-motivated and enthusiastic
Accountability Domain
Understand and comply with Standard Operating Procedures
Anticipate problems, issues, and proactively work to minimize the impact
Maintenance of strict confidentiality in all CAC-India projects
Responsible for Data Quality
Accountable for customer satisfaction of all CAC-India stakeholders
Build constructive and effective relationships with study team, departmental associates and others (both inside and outside the company).
Key Responsibilities: Safety Data Processing
Review and Assess all source documents and compile data in an adverse event report mentioned in the ICSR
Oversees and performs and ensures case receipt and triage activities are completed for Individual Case Safety Reports (ICSRs) from all sources and ensure this is performed in a timely manner Data enter report into the client safety database
Concentrate on quality of work to get error free data
Code averse events in the client safety database
Responsible for and ensures the reconciliation of the safety database with ICSR source files
Release reports to client through client safety database
May be asked to perform ICSR case processing activities as a backup for safety information cases (including initial data entry of safety information, initial determination of seriousness, expectedness, listedness, and Reportability.)
Effective communication with study teams and departmental associates
Check labelling and correct the information
Submit the report as per the timelines
Participates in or assists in leading special projects and process development or improvement activities
Provide support for business owner of global safety database and related systems (i.e. testing and validation, identification of database enhancements, change control activities.)
Additional Information Industry type
Pharma/ Biotech/ Clinical research
Functional Area
Life science
Location Mumbai Working Hours As per company policy or depending on Project requirement Travel Not Required Job Code R145 E-mail recruitbpo@usindia.com Sub Line REQ 2019 Q4 R145 Ref: (usindia)
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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