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Pharmacovigilance Coordinator
3 weeks ago
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- 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-
- Sub Line- REQ 2019 Q4 R143 Ref: (usindia)
