Roles and Responsibilities
- Perform QC review of ICSRs for completeness, accuracy, medical relevance and overall consistency of information captured in the safety database against all the applicable supporting documents as per the client requirement
- Demonstrate good technical competence of understanding of relationship of Partnership with Business Partners.
- Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
- Strong written and verbal communication/presentation skills.
- Being up-to-date with the latest technical/scientific developments and relating them to various projects.
Process Management - Control/reduce the cost of content development, cycle time and error rates in projects
Quality Management & Process Compliance to quality, confidentiality and security:
1. Adhere and follow quality systems, processes and policies
2. Comply to training and specifications
Team Management - Assisting and mentoring colleagues on the scientific formats required to review the documents
Provide guidance and support to all team members on a project with regard to format, style, content, and compliance.
Guide and mentor team members to ensure consistency and completeness of the project
Provide peer review for colleagues in support of all documents
Desired Candidate Profile
Life science Graduate/ post-graduate with 4+ years of experience in Pharmacovigilance, ICSR, Quality Assurance/QC.
Perks and Benefits
Role:Clinical Research Associate/Scientist
Salary: 5,00,000 - 15,00,000 P.A.
Employment Type:Full Time, Permanent
UG:B.Pharma in Any Specialization,BDS in Any Specialization,MBBS in Any Specialization
PG:MDS in Any Specialization,Medical-MS/MD in Any Specialization,M.Pharma in Any Specialization
M/s Gi Human Resources And Services Pvt. Ltd.
Pharma Client Of Gi
Contact Company:M/s Gi Human Resources And Services Pvt. Ltd.