Pharmacovigilance Coordinator Job in Unikaihatsu Software Private Limited
Pharmacovigilance Coordinator
Unikaihatsu Software Private Limited
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
- Permanent
Job Summary
Position Pharmacovigilance Coordinator 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 Data Entry experience preferred
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
Ensure the completeness of the documents, clinical safety data during data entry and tracking and interact with seniors on timely basis for further clarification if there are any discrepancies.
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
Interact with seniors for additional responsibilities other than Study Documents Tracking and Data Entry.
Concentrate on quality of work to get error free data.
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.)
Perform other related duties as required.
Effective communication with study teams and departmental associates.
Additional Information Industry type
Pharma/ Biotech/ Clinical research
Functional Area
Life science
Experience
Fresher or up to 1/1.5 years of Experience
Location Mumbai Working Hours As per company policy or depending on Project requirement Travel Not Required Job Code R143 E-mail recruitbpo@usindia.com Sub Line REQ 2019 Q4 R143 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 Data Entry experience preferred
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
Ensure the completeness of the documents, clinical safety data during data entry and tracking and interact with seniors on timely basis for further clarification if there are any discrepancies.
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
Interact with seniors for additional responsibilities other than Study Documents Tracking and Data Entry.
Concentrate on quality of work to get error free data.
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.)
Perform other related duties as required.
Effective communication with study teams and departmental associates.
Additional Information Industry type
Pharma/ Biotech/ Clinical research
Functional Area
Life science
Experience
Fresher or up to 1/1.5 years of Experience
Location Mumbai Working Hours As per company policy or depending on Project requirement Travel Not Required Job Code R143 E-mail recruitbpo@usindia.com Sub Line REQ 2019 Q4 R143 Ref: (usindia)
Experience Required :
Fresher
Vacancy :
2 - 4 Hires
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